Intraoperative Radiotherapy After Local Recurrence in Breast Cancer

NCT02386371 | Completed Results DMC

• 1 other identifier: ICM-URC2014/07
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 8

Brief Summary

The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer

  Fibrosis rate of RIOP grade 2 at 12 months of IORT (Intra Operative Radiotherapy) according to NCI CTCAE v4.0 classification grade 0 is the better outcomes Grade \>= 2 is the worse outcomes

  Up to 12 months post radiation

Secondary Outcomes (6)

• Rate of Early and Late Toxicities

  from the baseline to 5 years after treatment

• Local Relapse-free Survival

  from the baseline to 5 years after treatment

• Metastasis Relapse-free Survival

  from the baseline to 5 years after treatment

• Disease-free Survival.

  from the baseline to 5 years after treatment

• Overall Survival

  from the baseline to 5 years after treatment

Study Arms (1)

surgery and Intra Operative Radiotherapy

EXPERIMENTAL

Surgery : Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams. Intra Operative Radiotherapy (IORT): After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.

Procedure: tumorectomy; Radiation: Intra Operative Radiotherapy

Interventions

tumorectomy PROCEDURE

Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.

surgery and Intra Operative Radiotherapy

Intra Operative Radiotherapy RADIATION

After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure

surgery and Intra Operative Radiotherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven non-lobular invasive breast recurrence
• Time from whole breast radiation following the initial lumpectomy \>5 years
• Unifocal tumor
• Recurrent tumor size ≤ 2 cm
• Adequate breast size for a second breast-conserving surgery with acceptable cosmetic result
• Bilateral breast mammogram within 90 days prior to study entry
• Breast MRI within 90 days prior to study entry
• Histological grade I-II
• Estrogen-receptor-positive tumor (ER+)
• Cerb2-negative tumor
• Prior radiotherapy delivered within a standard fractionation schedule
• Performance status (ECOG) 0-1
• Women ≥ 50 years -Absence of any psychological, familial, sociological, or geographical conditions with a potential to hamper compliance with the study and follow- up schedule
• Affiliated to the French Health Insurance regimen
• Written and signed informed consent form.

You may not qualify if:

• Multifocal and/or multicenter recurrence
• Lobular carcinoma
• Estrogen-receptor-negative tumor (ER-)
• Cerb2 (her2) overexpressed - breast cancer
• Extensive intraductal component (EIC) on biopsy
• Lymph vessel invasion on biopsy
• N1-3 status: Regional cytological or histologically proven node recurrence
• M1 status: Metastatic disease
• cT4 (Skin or muscle involvement) or Paget's disease of the nipple
• Prior radiotherapy delivered within an accelerated or hypo-fraction schedule
• Prior malignancy other than non-melanoma skin cancer unless the patient has been disease free for at least 5 years
• Patients with a small breast volume, technically unsatisfactory for a second conservative surgery or intraoperative breast irradiation.
• Preoperative chemotherapy or hormone therapy for local relapse
• Connective tissue disease or scleroderma, contraindicating radiotherapy
• Known BRCA1/2 gene mutation (genetic testing is not required)

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (8)

Institut Bergonié

Bordeaux, 33000, France

Location

Chu Brest

Brest, France

Location

Centre George Francois Leclerc

Dijon, France

Location

Centre Léon Bérard

Lyon, 69, France

Location

CHU La TIMONE

Marseille, 13, France

Location

Institut Paoli Calmette

Marseille, 13, France

Location

ICM

Montpellier, 34298, France

Location

Institut de Cancérologie de l'Ouest

Nantes, France

Location

Related Publications (73)

• Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.

  PMID: 12393820 BACKGROUND

• Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.

  PMID: 12393819 BACKGROUND

• Brewster AM, Hortobagyi GN, Broglio KR, Kau SW, Santa-Maria CA, Arun B, Buzdar AU, Booser DJ, Valero V, Bondy M, Esteva FJ. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst. 2008 Aug 20;100(16):1179-83. doi: 10.1093/jnci/djn233. Epub 2008 Aug 11.

  PMID: 18695137 BACKGROUND

• Panet-Raymond V, Truong PT, Alexander C, Lesperance M, McDonald RE, Watson PH. Clinicopathologic factors of the recurrent tumor predict outcome in patients with ipsilateral breast tumor recurrence. Cancer. 2011 May 15;117(10):2035-43. doi: 10.1002/cncr.25767. Epub 2010 Nov 29.

  PMID: 21523714 BACKGROUND

• Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.

  PMID: 22019144 BACKGROUND

• Kurtz JM, Spitalier JM, Amalric R, Brandone H, Ayme Y, Jacquemier J, Hans D, Bressac C. The prognostic significance of late local recurrence after breast-conserving therapy. Int J Radiat Oncol Biol Phys. 1990 Jan;18(1):87-93. doi: 10.1016/0360-3016(90)90271-k.

  PMID: 2298639 BACKGROUND

• Hannoun-Levi JM, Resch A, Gal J, Kauer-Dorner D, Strnad V, Niehoff P, Loessl K, Kovacs G, Van Limbergen E, Polgar C; GEC-ESTRO Breast Cancer Working Group. Accelerated partial breast irradiation with interstitial brachytherapy as second conservative treatment for ipsilateral breast tumour recurrence: multicentric study of the GEC-ESTRO Breast Cancer Working Group. Radiother Oncol. 2013 Aug;108(2):226-31. doi: 10.1016/j.radonc.2013.03.026. Epub 2013 May 3.

  PMID: 23647758 BACKGROUND

• Moran MS, Haffty BG. Local-regional breast cancer recurrence: prognostic groups based on patterns of failure. Breast J. 2002 Mar-Apr;8(2):81-7. doi: 10.1046/j.1524-4741.2002.08202.x.

  PMID: 11896752 BACKGROUND

• Fourquet A, Campana F, Zafrani B, Mosseri V, Vielh P, Durand JC, Vilcoq JR. Prognostic factors of breast recurrence in the conservative management of early breast cancer: a 25-year follow-up. Int J Radiat Oncol Biol Phys. 1989 Oct;17(4):719-25. doi: 10.1016/0360-3016(89)90057-6.

  PMID: 2777661 BACKGROUND

• Fisher B, Anderson S, Fisher ER, Redmond C, Wickerham DL, Wolmark N, Mamounas EP, Deutsch M, Margolese R. Significance of ipsilateral breast tumour recurrence after lumpectomy. Lancet. 1991 Aug 10;338(8763):327-31. doi: 10.1016/0140-6736(91)90475-5.

  PMID: 1677695 BACKGROUND

• Veronesi U, Marubini E, Del Vecchio M, Manzari A, Andreola S, Greco M, Luini A, Merson M, Saccozzi R, Rilke F, et al. Local recurrences and distant metastases after conservative breast cancer treatments: partly independent events. J Natl Cancer Inst. 1995 Jan 4;87(1):19-27. doi: 10.1093/jnci/87.1.19.

  PMID: 7666458 BACKGROUND

• Tanis E, van de Velde CJ, Bartelink H, van de Vijver MJ, Putter H, van der Hage JA. Locoregional recurrence after breast-conserving therapy remains an independent prognostic factor even after an event free interval of 10 years in early stage breast cancer. Eur J Cancer. 2012 Aug;48(12):1751-6. doi: 10.1016/j.ejca.2012.02.051. Epub 2012 Mar 23.

  PMID: 22446021 BACKGROUND

• Schmoor C, Sauerbrei W, Bastert G, Schumacher M. Role of isolated locoregional recurrence of breast cancer: results of four prospective studies. J Clin Oncol. 2000 Apr;18(8):1696-708. doi: 10.1200/JCO.2000.18.8.1696.

  PMID: 10764430 BACKGROUND

• Anderson SJ, Wapnir I, Dignam JJ, Fisher B, Mamounas EP, Jeong JH, Geyer CE Jr, Wickerham DL, Costantino JP, Wolmark N. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol. 2009 May 20;27(15):2466-73. doi: 10.1200/JCO.2008.19.8424. Epub 2009 Apr 6.

  PMID: 19349544 BACKGROUND

• van der Sangen MJ, van de Poll-Franse LV, Roumen RM, Rutten HJ, Coebergh JW, Vreugdenhil G, Voogd AC. The prognosis of patients with local recurrence more than five years after breast conservation therapy for invasive breast carcinoma. Eur J Surg Oncol. 2006 Feb;32(1):34-8. doi: 10.1016/j.ejso.2005.10.005. Epub 2005 Nov 21.

  PMID: 16305821 BACKGROUND

• Galper S, Blood E, Gelman R, Abner A, Recht A, Kohli A, Wong JS, Smith D, Bellon J, Connolly J, Schnitt S, Winer E, Silver B, Harris JR. Prognosis after local recurrence after conservative surgery and radiation for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):348-57. doi: 10.1016/j.ijrobp.2004.06.011.

  PMID: 15667952 BACKGROUND

• Le MG, Arriagada R, Spielmann M, Guinebretiere JM, Rochard F. Prognostic factors for death after an isolated local recurrence in patients with early-stage breast carcinoma. Cancer. 2002 Jun 1;94(11):2813-20. doi: 10.1002/cncr.10572.

  PMID: 12115367 BACKGROUND

• Courdi A, Doyen J, Gal J, Chamorey E. Local recurrence after breast cancer affects specific survival differently according to patient age. Oncology. 2010;79(5-6):349-54. doi: 10.1159/000323483. Epub 2011 Mar 23.

  PMID: 21430403 BACKGROUND

• Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.

  PMID: 25605582 BACKGROUND

• Sabatier R, Finetti P, Cervera N, Tallet A, Benchalal M, Houvenaeghel G, Jacquemier J, Birnbaum D, Bertucci F. Gene expression profiling and its utility in prediction of local relapse after breast-conserving therapy in early breast cancer. Cancer Genomics Proteomics. 2011 Jul-Aug;8(4):199-209.

  PMID: 21737613 BACKGROUND

• Kurtz JM, Jacquemier J, Amalric R, Brandone H, Ayme Y, Hans D, Bressac C, Spitalier JM. Is breast conservation after local recurrence feasible? Eur J Cancer. 1991;27(3):240-4. doi: 10.1016/0277-5379(91)90505-8.

  PMID: 1827303 BACKGROUND

• Salvadori B, Marubini E, Miceli R, Conti AR, Cusumano F, Andreola S, Zucali R, Veronesi U. Reoperation for locally recurrent breast cancer in patients previously treated with conservative surgery. Br J Surg. 1999 Jan;86(1):84-7. doi: 10.1046/j.1365-2168.1999.00961.x.

  PMID: 10027366 BACKGROUND

• Alpert TE, Kuerer HM, Arthur DW, Lannin DR, Haffty BG. Ipsilateral breast tumor recurrence after breast conservation therapy: outcomes of salvage mastectomy vs. salvage breast-conserving surgery and prognostic factors for salvage breast preservation. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):845-51. doi: 10.1016/j.ijrobp.2005.02.035.

  PMID: 16199315 BACKGROUND

• Gentilini O, Botteri E, Veronesi P, Sangalli C, Del Castillo A, Ballardini B, Galimberti V, Rietjens M, Colleoni M, Luini A, Veronesi U. Repeating conservative surgery after ipsilateral breast tumor reappearance: criteria for selecting the best candidates. Ann Surg Oncol. 2012 Nov;19(12):3771-6. doi: 10.1245/s10434-012-2404-5. Epub 2012 May 23.

  PMID: 22618719 BACKGROUND

• Deutsch M. Repeat high-dose external beam irradiation for in-breast tumor recurrence after previous lumpectomy and whole breast irradiation. Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):687-91. doi: 10.1016/s0360-3016(02)02785-2.

  PMID: 12062613 BACKGROUND

• Hannoun-Levi JM, Ihrai T, Courdi A. Local treatment options for ipsilateral breast tumour recurrence. Cancer Treat Rev. 2013 Nov;39(7):737-41. doi: 10.1016/j.ctrv.2013.02.003. Epub 2013 Mar 5.

  PMID: 23465859 BACKGROUND

• Chadha M, Feldman S, Boolbol S, Wang L, Harrison LB. The feasibility of a second lumpectomy and breast brachytherapy for localized cancer in a breast previously treated with lumpectomy and radiation therapy for breast cancer. Brachytherapy. 2008 Jan-Mar;7(1):22-8. doi: 10.1016/j.brachy.2007.10.006.

  PMID: 18299110 BACKGROUND

• Trombetta M, Julian TB, Werts ED, Colonias A, Betler J, Kotinsley K, Kim Y, Parda D. Comparison of conservative management techniques in the re-treatment of ipsilateral breast tumor recurrence. Brachytherapy. 2011 Jan-Feb;10(1):74-80. doi: 10.1016/j.brachy.2010.01.005. Epub 2010 Aug 4.

  PMID: 20685174 BACKGROUND

• Wapnir IL, Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Mamounas EP, Wolmark N. Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg Oncol. 2008 Nov;15(11):3227-31. doi: 10.1245/s10434-008-0129-2. Epub 2008 Sep 11.

  PMID: 18784962 BACKGROUND

• Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Martin M, Nortier JW, Paterson AH, Rimawi MF, Canada JM, Thurlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16.

  PMID: 24439313 BACKGROUND

• Borner M, Bacchi M, Goldhirsch A, Greiner R, Harder F, Castiglione M, Jungi WF, Thurlimann B, Cavalli F, Obrecht JP, et al. First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research. J Clin Oncol. 1994 Oct;12(10):2071-7. doi: 10.1200/JCO.1994.12.10.2071.

  PMID: 7931476 BACKGROUND

• Waeber M, Castiglione-Gertsch M, Dietrich D, Thurlimann B, Goldhirsch A, Brunner KW, Borner MM; Swiss Group for Clinical Cancer Research (SAKK). Adjuvant therapy after excision and radiation of isolated postmastectomy locoregional breast cancer recurrence: definitive results of a phase III randomized trial (SAKK 23/82) comparing tamoxifen with observation. Ann Oncol. 2003 Aug;14(8):1215-21. doi: 10.1093/annonc/mdg347.

  PMID: 12881382 BACKGROUND

• Doyle T, Schultz DJ, Peters C, Harris E, Solin LJ. Long-term results of local recurrence after breast conservation treatment for invasive breast cancer. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):74-80. doi: 10.1016/s0360-3016(01)01625-x.

  PMID: 11516854 BACKGROUND

• Abner AL, Recht A, Eberlein T, Come S, Shulman L, Hayes D, Connolly JL, Schnitt SJ, Silver B, Harris JR. Prognosis following salvage mastectomy for recurrence in the breast after conservative surgery and radiation therapy for early-stage breast cancer. J Clin Oncol. 1993 Jan;11(1):44-8. doi: 10.1200/JCO.1993.11.1.44.

  PMID: 8418240 BACKGROUND

• Voogd AC, van Tienhoven G, Peterse HL, Crommelin MA, Rutgers EJ, van de Velde CJ, van Geel BN, Slot A, Rodrigus PT, Jobsen JJ, von Meyenfeldt MF, Coebergh JW. Local recurrence after breast conservation therapy for early stage breast carcinoma: detection, treatment, and outcome in 266 patients. Dutch Study Group on Local Recurrence after Breast Conservation (BORST). Cancer. 1999 Jan 15;85(2):437-46. doi: 10.1002/(sici)1097-0142(19990115)85:23.0.co;2-1.

  PMID: 10023713 BACKGROUND

• Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M; Society of Surgical Oncology; American Society for Radiation Oncology. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. J Clin Oncol. 2014 May 10;32(14):1507-15. doi: 10.1200/JCO.2013.53.3935. Epub 2014 Feb 10.

  PMID: 24516019 BACKGROUND

• Dalberg K, Mattsson A, Sandelin K, Rutqvist LE. Outcome of treatment for ipsilateral breast tumor recurrence in early-stage breast cancer. Breast Cancer Res Treat. 1998 May;49(1):69-78. doi: 10.1023/a:1005934513072.

  PMID: 9694613 BACKGROUND

• Ishitobi M, Komoike Y, Nakahara S, Motomura K, Koyama H, Inaji H. Repeat lumpectomy for ipsilateral breast tumor recurrence after breast-conserving treatment. Oncology. 2011;81(5-6):381-6. doi: 10.1159/000335265. Epub 2012 Jan 20.

  PMID: 22269927 BACKGROUND

• Chen SL, Martinez SR. The survival impact of the choice of surgical procedure after ipsilateral breast cancer recurrence. Am J Surg. 2008 Oct;196(4):495-9. doi: 10.1016/j.amjsurg.2008.06.018.

  PMID: 18809050 BACKGROUND

• Holland R, Veling SH, Mravunac M, Hendriks JH. Histologic multifocality of Tis, T1-2 breast carcinomas. Implications for clinical trials of breast-conserving surgery. Cancer. 1985 Sep 1;56(5):979-90. doi: 10.1002/1097-0142(19850901)56:53.0.co;2-n.

  PMID: 2990668 BACKGROUND

• Smith TE, Lee D, Turner BC, Carter D, Haffty BG. True recurrence vs. new primary ipsilateral breast tumor relapse: an analysis of clinical and pathologic differences and their implications in natural history, prognoses, and therapeutic management. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1281-9. doi: 10.1016/s0360-3016(00)01378-x.

  PMID: 11121624 BACKGROUND

• Fredriksson I, Liljegren G, Arnesson LG, Emdin SO, Palm-Sjovall M, Fornander T, Holmqvist M, Holmberg L, Frisell J. Local recurrence in the breast after conservative surgery--a study of prognosis and prognostic factors in 391 women. Eur J Cancer. 2002 Sep;38(14):1860-70. doi: 10.1016/s0959-8049(02)00219-8.

  PMID: 12204668 BACKGROUND

• Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C, Alvarado M, Flyger HL, Massarut S, Eiermann W, Keshtgar M, Dewar J, Kraus-Tiefenbacher U, Sutterlin M, Esserman L, Holtveg HM, Roncadin M, Pigorsch S, Metaxas M, Falzon M, Matthews A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet. 2010 Jul 10;376(9735):91-102. doi: 10.1016/S0140-6736(10)60837-9.

  PMID: 20570343 BACKGROUND

• Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg. 2009 Aug;209(2):269-77. doi: 10.1016/j.jamcollsurg.2009.02.066. Epub 2009 Apr 24. No abstract available.

  PMID: 19632605 BACKGROUND

• Polgar C, Van Limbergen E, Potter R, Kovacs G, Polo A, Lyczek J, Hildebrandt G, Niehoff P, Guinot JL, Guedea F, Johansson B, Ott OJ, Major T, Strnad V; GEC-ESTRO breast cancer working group. Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: recommendations of the Groupe Europeen de Curietherapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009). Radiother Oncol. 2010 Mar;94(3):264-73. doi: 10.1016/j.radonc.2010.01.014. Epub 2010 Feb 22.

  PMID: 20181402 BACKGROUND

• Hannoun-Levi JM, Houvenaeghel G, Ellis S, Teissier E, Alzieu C, Lallement M, Cowen D. Partial breast irradiation as second conservative treatment for local breast cancer recurrence. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1385-92. doi: 10.1016/j.ijrobp.2004.05.035.

  PMID: 15590169 BACKGROUND

• Resch A, Fellner C, Mock U, Handl-Zeller L, Biber E, Seitz W, Potter R. Locally recurrent breast cancer: pulse dose rate brachytherapy for repeat irradiation following lumpectomy-- a second chance to preserve the breast. Radiology. 2002 Dec;225(3):713-8. doi: 10.1148/radiol.2253011913.

  PMID: 12461250 BACKGROUND

• Kraus-Tiefenbacher U, Bauer L, Scheda A, Schoeber C, Schaefer J, Steil V, Wenz F. Intraoperative radiotherapy (IORT) is an option for patients with localized breast recurrences after previous external-beam radiotherapy. BMC Cancer. 2007 Sep 14;7:178. doi: 10.1186/1471-2407-7-178.

  PMID: 17854511 BACKGROUND

• Kauer-Dorner D, Potter R, Resch A, Handl-Zeller L, Kirchheiner K, Meyer-Schell K, Dorr W. Partial breast irradiation for locally recurrent breast cancer within a second breast conserving treatment: alternative to mastectomy? Results from a prospective trial. Radiother Oncol. 2012 Jan;102(1):96-101. doi: 10.1016/j.radonc.2011.07.020. Epub 2011 Sep 8.

  PMID: 21907439 BACKGROUND

• Guix B, Lejarcegui JA, Tello JI, Zanon G, Henriquez I, Finestres F, Martinez A, Fernandez-Ibiza J, Quinzanos L, Palombo P, Encinas X, Guix I. Exeresis and brachytherapy as salvage treatment for local recurrence after conservative treatment for breast cancer: results of a ten-year pilot study. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):804-10. doi: 10.1016/j.ijrobp.2009.08.009. Epub 2010 Jan 26.

  PMID: 20106605 BACKGROUND

• Nairz O, Deutschmann H, Kopp M, Wurstbauer K, Kametriser G, Fastner G, Merz F, Reitsamer R, Menzel C, Sedlmayer F. A dosimetric comparison of IORT techniques in limited-stage breast cancer. Strahlenther Onkol. 2006 Jun;182(6):342-8. doi: 10.1007/s00066-006-1580-2.

  PMID: 16703290 BACKGROUND

• Herskind C, Griebel J, Kraus-Tiefenbacher U, Wenz F. Sphere of equivalence--a novel target volume concept for intraoperative radiotherapy using low-energy X rays. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1575-81. doi: 10.1016/j.ijrobp.2008.08.009.

  PMID: 19028280 BACKGROUND

• Liu Q, Schneider F, Ma L, Wenz F, Herskind C. Relative Biologic Effectiveness (RBE) of 50 kV X-rays measured in a phantom for intraoperative tumor-bed irradiation. Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):1127-33. doi: 10.1016/j.ijrobp.2012.08.005. Epub 2012 Sep 14.

  PMID: 22981707 BACKGROUND

• Reitsamer R, Fastner G, Kopp M, Menzel C, Sedlmayer F. Intraoperative radiotherapy for early breast cancer. Lancet. 2010 Oct 2;376(9747):1141; author reply 1143-4. doi: 10.1016/S0140-6736(10)61529-2. No abstract available.

  PMID: 20888980 BACKGROUND

• Smith BD, Buchholz TA, Kuerer HM. Intraoperative radiotherapy for early breast cancer. Lancet. 2010 Oct 2;376(9747):1141; author reply 1143-4. doi: 10.1016/S0140-6736(10)61530-9. No abstract available.

  PMID: 20888981 BACKGROUND

• Reitsamer R, Sedlmayer F, Kopp M, Kametriser G, Menzel C, Deutschmann H, Nairz O, Hitzl W, Peintinger F. The Salzburg concept of intraoperative radiotherapy for breast cancer: results and considerations. Int J Cancer. 2006 Jun 1;118(11):2882-7. doi: 10.1002/ijc.21727.

  PMID: 16381011 BACKGROUND

• Dubois JB, Hay M, Gely S, Saint-Aubert B, Rouanet P, Pujol H. IORT in breast carcinomas. Front Radiat Ther Oncol. 1997;31:131-7. doi: 10.1159/000061160. No abstract available.

  PMID: 9263806 BACKGROUND

• Fastner G, Sedlmayer F, Merz F, Deutschmann H, Reitsamer R, Menzel C, Stierle C, Farmini A, Fischer T, Ciabattoni A, Mirri A, Hager E, Reinartz G, Lemanski C, Orecchia R, Valentini V. IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: long term results of an ISIORT pooled analysis. Radiother Oncol. 2013 Aug;108(2):279-86. doi: 10.1016/j.radonc.2013.05.031. Epub 2013 Jul 2.

  PMID: 23830467 BACKGROUND

• Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. doi: 10.1016/j.ijrobp.2005.10.025. Epub 2006 Jan 25.

  PMID: 16442241 BACKGROUND

• Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.

  PMID: 19467579 BACKGROUND

• Welzel G, Boch A, Sperk E, Hofmann F, Kraus-Tiefenbacher U, Gerhardt A, Suetterlin M, Wenz F. Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Radiat Oncol. 2013 Jan 7;8:9. doi: 10.1186/1748-717X-8-9.

  PMID: 23294485 BACKGROUND

• Sperk E, Welzel G, Keller A, Kraus-Tiefenbacher U, Gerhardt A, Sutterlin M, Wenz F. Late radiation toxicity after intraoperative radiotherapy (IORT) for breast cancer: results from the randomized phase III trial TARGIT A. Breast Cancer Res Treat. 2012 Aug;135(1):253-60. doi: 10.1007/s10549-012-2168-4. Epub 2012 Jul 29.

  PMID: 22842984 BACKGROUND

• Grobmyer SR, Lightsey JL, Bryant CM, Shaw C, Yeung A, Bhandare N, Hitchingham B, Copeland EM 3rd. Low-kilovoltage, single-dose intraoperative radiation therapy for breast cancer: results and impact on a multidisciplinary breast cancer program. J Am Coll Surg. 2013 Apr;216(4):617-23; discussion 623-4. doi: 10.1016/j.jamcollsurg.2012.12.038. Epub 2013 Feb 14.

  PMID: 23415885 BACKGROUND

• Keshtgar MR, Williams NR, Bulsara M, Saunders C, Flyger H, Cardoso JS, Corica T, Bentzon N, Michalopoulos NV, Joseph DJ. Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy in breast cancer: results from a randomised controlled trial. Breast Cancer Res Treat. 2013 Aug;140(3):519-25. doi: 10.1007/s10549-013-2641-8. Epub 2013 Jul 23.

  PMID: 23877341 BACKGROUND

• Dubois JB, Gu SD, Hay MH, Gely S, Delard R, Joyeux H, Solassol C, Pujol H. Intra-operative radiation therapy (IORT) with 100 kV X photons. Experience on 170 patients. Pathol Biol (Paris). 1992 Nov;39(9):884-5. No abstract available.

  PMID: 1538921 BACKGROUND

• Lemanski C, Azria D, Gourgou-Bourgade S, Ailleres N, Pastant A, Rouanet P, Fenoglietto P, Dubois JB, Gutowski M. Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial. Radiat Oncol. 2013 Aug 1;8:191. doi: 10.1186/1748-717X-8-191.

  PMID: 23902825 BACKGROUND

• Neumaier C, Elena S, Grit W, Yasser AM, Uta KT, Anke K, Axel G, Marc S, Frederik W. TARGIT-E(lderly)--prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer. BMC Cancer. 2012 May 8;12:171. doi: 10.1186/1471-2407-12-171.

  PMID: 22569123 BACKGROUND

• Azria D, Belkacemi Y, Romieu G, Gourgou S, Gutowski M, Zaman K, Moscardo CL, Lemanski C, Coelho M, Rosenstein B, Fenoglietto P, Crompton NE, Ozsahin M. Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. Lancet Oncol. 2010 Mar;11(3):258-65. doi: 10.1016/S1470-2045(10)70013-9. Epub 2010 Feb 6.

  PMID: 20138810 BACKGROUND

• Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33. doi: 10.1158/1078-0432.CCR-04-2634.

  PMID: 16243816 BACKGROUND

• Rothkamm K, Beinke C, Romm H, Badie C, Balagurunathan Y, Barnard S, Bernard N, Boulay-Greene H, Brengues M, De Amicis A, De Sanctis S, Greither R, Herodin F, Jones A, Kabacik S, Knie T, Kulka U, Lista F, Martigne P, Missel A, Moquet J, Oestreicher U, Peinnequin A, Poyot T, Roessler U, Scherthan H, Terbrueggen B, Thierens H, Valente M, Vral A, Zenhausern F, Meineke V, Braselmann H, Abend M. Comparison of established and emerging biodosimetry assays. Radiat Res. 2013 Aug;180(2):111-9. doi: 10.1667/RR3231.1. Epub 2013 Jul 17.

  PMID: 23862692 BACKGROUND

• Templin T, Paul S, Amundson SA, Young EF, Barker CA, Wolden SL, Smilenov LB. Radiation-induced micro-RNA expression changes in peripheral blood cells of radiotherapy patients. Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):549-57. doi: 10.1016/j.ijrobp.2010.12.061. Epub 2011 Mar 21.

  PMID: 21420249 BACKGROUND

• Park SH, Kim MJ, Park BW, Moon HJ, Kwak JY, Kim EK. Impact of preoperative ultrasonography and fine-needle aspiration of axillary lymph nodes on surgical management of primary breast cancer. Ann Surg Oncol. 2011 Mar;18(3):738-44. doi: 10.1245/s10434-010-1347-y. Epub 2010 Oct 2.

  PMID: 20890729 BACKGROUND

• MacNeill M, Arnott I, Thomas J. Fine needle aspiration cytology is a valuable adjunct to axillary ultrasound in the preoperative staging of breast cancer. J Clin Pathol. 2011 Jan;64(1):42-6. doi: 10.1136/jcp.2010.083063. Epub 2010 Nov 19.

  PMID: 21097541 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation
• Organization: INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

drci-icm105@icm.unicancer.fr

0467613102

Study Officials

• LEMANSKI Claire

  Institut régional du Cancer - Val d'Aurelle

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 11, 2015
• Study Start: March 1, 2014
• Primary Completion: June 12, 2020
• Study Completion: September 18, 2023
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Locations

FR (8)