Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer

NCT02858934 | Completed

• 1 other identifier: CHUB-Preop-Breast
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

The standard treatment for women with a relatively small breast cancer without arguments for involvement of the axillary lymph nodes, is breast conserving surgery followed by radiotherapy of the whole breast, often with a complementary dose to the operated area (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in quality of life. Randomized trials have shown that shorter schedules, delivering slightly more dose per day during 3 weeks, are equal to the long schedules. In an earlier clinical study, the investigators have tested such a short schedule and shown that it is equally safe and equally well tolerated as the conventional schemes. Other hospitals have examined (and still are examining) the safety and tolerance of even shorter schedules, delivering radiotherapy in 1 week. This clinical study involves delivering radiotherapy in 1 week and before the surgery in stead of following surgery. In the postoperative setting, it is often debatable which volume should be included in the boost. Often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the tumor is visible on imaging. This can result in smaller boost volumes. The surgery will follow shortly after termination of the radiotherapy, resulting in a very short treatment period. This study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer.

Conditions

Breast Cancer

Keywords

Short preoperative tomotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (6)

• Duration of the surgical procedure

  Duration of the breast conserving surgery (lumpectomy + sentinel lymph node procedure)

  from 2 to 8 days after the last radiotherapy session.

• Quantity of blood lost

  Quantity of blood that has been lost during the breast conservation surgery, performed 2 to 8 days after the last radiotherapy session.

  from 2 to 8 days after the last radiotherapy session.

• Dindo score

  Post operative morbidity assessment according to Dindo, Demartines et al.

  Week 6 after radiotherapy start

• Wound disruption (yes/no)

  Presence of wound disruption defined as skin dehiscence from any cause including seroma or hematoma.

  up to 30 days post operative

• Wound infection (yes/no)

  Presence of wound infection, defined as: purulent drainage, cellulitis, abscess or wound requiring drainage, debriding, and antibiotics associated with a clinical diagnosis of infection.

  up to 30 days post operative

• Number of adverse events

  Acute radiation toxicity measure

  up to three months after radiotherapy start

Secondary Outcomes (6)

• QLQ-C30 questionnaire

  week 3 after radiotherapy start

• QLQ-C30 questionnaire

  week 6 after radiotherapy start

• EORTC QLQ-BR23 questionnaire

  week 3 after radiotherapy start

• EORTC QLQ-BR23 questionnaire

  week 6 after radiotherapy start

• Number of adverse events

  from three months after radiotherapy start till end of study (up to 1 years)

Study Arms (1)

preoperative tomotherapy

EXPERIMENTAL

This study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer, including approximately 24 women. Radiotherapy will be performed in 1 week and before the surgery in stead of following surgery.Preoperative radiotherapy has the advantage that the tumor is visible on imaging. This can result in smaller boost volumes. The surgery will follow shortly after termination of the radiotherapy, resulting in a very short treatment period.

Radiation: Tomotherapy

Interventions

Tomotherapy RADIATION

Dose prescription: Whole breast irradiation: 25 Gy in 5 daily fractions of 5 Gy Boost: 30 Gy in 5 daily fractions of 6 Gy The boost will be delivered as a simultaneous integrated boost (SIB). Target volumes: Clinical target volume (CTV) breast: defined by the soft tissue of the breast down to the pectoralis fascia, but excluding the skin and the underlying muscle, ribs, lung and heart. Gross tumor volume (GTV) boost: includes all gross tumor volume, as visible on computer tomography, mammography and/or magnetic resonance imaging (MRI). MRI imaging is preferentially performed in treatment position. CTV boost: includes the primary tumor, with a margin of 1.0 cm in all directions to encompass potential microscopic disease extension. The CTV boost excludes the skin, pectoralis muscle, ribs, lung and heart. Planning target volume (PTV): CTV plus a margin of 5 mm in all directions, but limited at 5 mm below the skin surface.

preoperative tomotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Histological diagnosis of unifocal invasive breast carcinoma, no special type (ductal carcinoma)
• Tumor Staging: cT1-2N0M0
• Luminal A or B
• Candidate for breast conserving surgery
• N0-status confirmed by lymph node cytology

You may not qualify if:

• Multifocal/multicentric disease
• Prior thoracic radiotherapy
• Pregnancy
• SBR3 grading
• Triple negative status which benefit neoadjuvant chemotherapy

Sponsors & Collaborators

• Andre Nazac: lead

Study Sites (3)

CHU Brugmann

Brussels, 1020, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

AZ Sint Blasius

Dendermonde, 9200, Belgium

Location

Related Publications (10)

• Senkus E, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rutgers E, Zackrisson S, Cardoso F; ESMO Guidelines Committee. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30. doi: 10.1093/annonc/mdv298. No abstract available.

  PMID: 26314782 BACKGROUND

• Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.

  PMID: 17577015 BACKGROUND

• Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.

  PMID: 20147717 BACKGROUND

• Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.

  PMID: 24055415 BACKGROUND

• Van Parijs H, Miedema G, Vinh-Hung V, Verbanck S, Adriaenssens N, Kerkhove D, Reynders T, Schuermans D, Leysen K, Hanon S, Van Camp G, Vincken W, Storme G, Verellen D, De Ridder M. Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial. Radiat Oncol. 2012 Jun 1;7:80. doi: 10.1186/1748-717X-7-80.

  PMID: 22656865 BACKGROUND

• Versmessen H, Vinh-Hung V, Van Parijs H, Miedema G, Voordeckers M, Adriaenssens N, Storme G, De Ridder M. Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy. BMC Cancer. 2012 Oct 25;12:495. doi: 10.1186/1471-2407-12-495.

  PMID: 23098579 BACKGROUND

• van Mourik AM, Elkhuizen PH, Minkema D, Duppen JC; Dutch Young Boost Study Group; van Vliet-Vroegindeweij C. Multiinstitutional study on target volume delineation variation in breast radiotherapy in the presence of guidelines. Radiother Oncol. 2010 Mar;94(3):286-91. doi: 10.1016/j.radonc.2010.01.009. Epub 2010 Mar 2.

  PMID: 20199818 BACKGROUND

• Kirby AN, Jena R, Harris EJ, Evans PM, Crowley C, Gregory DL, Coles CE. Tumour bed delineation for partial breast/breast boost radiotherapy: what is the optimal number of implanted markers? Radiother Oncol. 2013 Feb;106(2):231-5. doi: 10.1016/j.radonc.2013.02.003. Epub 2013 Mar 13.

  PMID: 23490269 BACKGROUND

• Nichols EM, Dhople AA, Mohiuddin MM, Flannery TW, Yu CX, Regine WF. Comparative analysis of the post-lumpectomy target volume versus the use of pre-lumpectomy tumor volume for early-stage breast cancer: implications for the future. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):197-202. doi: 10.1016/j.ijrobp.2009.04.063.

  PMID: 20394853 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Mark De Ridder, MD

  CHU Brugmann/UZ Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 8, 2016
• Study Start: March 8, 2017
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

BE (3)