Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.

NCT04646772 | Unknown DMC

• 1 other identifier: LACC Trial
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Conditions

Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4

Outcome Measures

Primary Outcomes (2)

• Postoperative morbidity

  I evaluate peri and post-operative surgical (e.g. intraabdominal collection, fistula, anastomotic leak) and medical (e.g. pneumoniae, deep vein thrombosis) complications

  30 days

• Postoperative mortality

  I evaluate in-hospital and 30-day mortality correlate to the intervention

  30 days

Secondary Outcomes (2)

• Overall Survival

  5 years

• Disease Free Survival

  5 years

Interventions

Multivisceral resection PROCEDURE

Multivisceral resection for locally advanced colon cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

You may qualify if:

• \> 18 aa
• Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

You may not qualify if:

• Stage IV
• Rectal cancer
• Emergency surgery (\<48 hours from admission)
• ASA \> III

Sponsors & Collaborators

• Santo Spirito Hospital, Italy: lead

Related Publications (27)

• Gebhardt C, Meyer W, Ruckriegel S, Meier U. Multivisceral resection of advanced colorectal carcinoma. Langenbecks Arch Surg. 1999 Apr;384(2):194-9. doi: 10.1007/s004230050191.

  PMID: 10328174 BACKGROUND

• Sugarbaker PH, Corlew S. Influence of surgical techniques on survival in patients with colorectal cancer. Dis Colon Rectum. 1982 Sep;25(6):545-57. doi: 10.1007/BF02564164.

  PMID: 6749455 BACKGROUND

• Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.

  PMID: 20180029 BACKGROUND

• Vieira RA, Lopes A, Almeida PA, Rossi BM, Nakagawa WT, Ferreira FO, Melo CA. Prognostic factors in locally advanced colon cancer treated by extended resection. Rev Hosp Clin Fac Med Sao Paulo. 2004 Dec;59(6):361-8. doi: 10.1590/s0041-87812004000600009. Epub 2005 Jan 11.

  PMID: 15654490 BACKGROUND

• Pittam MR, Thornton H, Ellis H. Survival after extended resection for locally advanced carcinomas of the colon and rectum. Ann R Coll Surg Engl. 1984 Mar;66(2):81-4.

  PMID: 6703633 BACKGROUND

• Courtney D, McDermott F, Heeney A, Winter DC. Clinical review: surgical management of locally advanced and recurrent colorectal cancer. Langenbecks Arch Surg. 2014 Jan;399(1):33-40. doi: 10.1007/s00423-013-1134-x. Epub 2013 Nov 19.

  PMID: 24249035 BACKGROUND

• Croner RS, Merkel S, Papadopoulos T, Schellerer V, Hohenberger W, Goehl J. Multivisceral resection for colon carcinoma. Dis Colon Rectum. 2009 Aug;52(8):1381-6. doi: 10.1007/DCR.0b013e3181ab580b.

  PMID: 19617748 BACKGROUND

• Hoffmann M, Phillips C, Oevermann E, Killaitis C, Roblick UJ, Hildebrand P, Buerk CG, Wolken H, Kujath P, Schloericke E, Bruch HP. Multivisceral and standard resections in colorectal cancer. Langenbecks Arch Surg. 2012 Jan;397(1):75-84. doi: 10.1007/s00423-011-0854-z. Epub 2011 Oct 4.

  PMID: 21968828 BACKGROUND

• Mohan HM, Evans MD, Larkin JO, Beynon J, Winter DC. Multivisceral resection in colorectal cancer: a systematic review. Ann Surg Oncol. 2013 Sep;20(9):2929-36. doi: 10.1245/s10434-013-2967-9. Epub 2013 May 11.

  PMID: 23666095 BACKGROUND

• Zoucas E, Frederiksen S, Lydrup ML, Mansson W, Gustafson P, Alberius P. Pelvic exenteration for advanced and recurrent malignancy. World J Surg. 2010 Sep;34(9):2177-84. doi: 10.1007/s00268-010-0637-7.

  PMID: 20512493 BACKGROUND

• Chang GJ, Kaiser AM, Mills S, Rafferty JF, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of colon cancer. Dis Colon Rectum. 2012 Aug;55(8):831-43. doi: 10.1097/DCR.0b013e3182567e13. No abstract available.

  PMID: 22810468 BACKGROUND

• Kapoor S, Das B, Pal S, Sahni P, Chattopadhyay TK. En bloc resection of right-sided colonic adenocarcinoma with adjacent organ invasion. Int J Colorectal Dis. 2006 Apr;21(3):265-8. doi: 10.1007/s00384-005-0756-z. Epub 2005 Jun 7.

  PMID: 15940511 BACKGROUND

• Landmann RG, Weiser MR. Surgical management of locally advanced and locally recurrent colon cancer. Clin Colon Rectal Surg. 2005 Aug;18(3):182-9. doi: 10.1055/s-2005-916279.

  PMID: 20011301 BACKGROUND

• Lehnert T, Methner M, Pollok A, Schaible A, Hinz U, Herfarth C. Multivisceral resection for locally advanced primary colon and rectal cancer: an analysis of prognostic factors in 201 patients. Ann Surg. 2002 Feb;235(2):217-25. doi: 10.1097/00000658-200202000-00009.

  PMID: 11807361 BACKGROUND

• Lopez-Cano M, Manas MJ, Hermosilla E, Espin E. Multivisceral resection for colon cancer: analysis of prognostic factors. Dig Surg. 2010 Aug;27(3):238-45. doi: 10.1159/000276974. Epub 2010 Jun 22.

  PMID: 20571272 BACKGROUND

• Eveno C, Lefevre JH, Svrcek M, Bennis M, Chafai N, Tiret E, Parc Y. Oncologic results after multivisceral resection of clinical T4 tumors. Surgery. 2014 Sep;156(3):669-75. doi: 10.1016/j.surg.2014.03.040. Epub 2014 Jun 19.

  PMID: 24953279 BACKGROUND

• Cukier M, Smith AJ, Milot L, Chu W, Chung H, Fenech D, Herschorn S, Ko Y, Rowsell C, Soliman H, Ung YC, Wong CS. Neoadjuvant chemoradiotherapy and multivisceral resection for primary locally advanced adherent colon cancer: a single institution experience. Eur J Surg Oncol. 2012 Aug;38(8):677-82. doi: 10.1016/j.ejso.2012.05.001. Epub 2012 May 24.

  PMID: 22632848 BACKGROUND

• Darakhshan A, Lin BP, Chan C, Chapuis PH, Dent OF, Bokey L. Correlates and outcomes of tumor adherence in resected colonic and rectal cancers. Ann Surg. 2008 Apr;247(4):650-8. doi: 10.1097/SLA.0b013e318163d264.

  PMID: 18362628 BACKGROUND

• Hunter JA, Ryan JA Jr, Schultz P. En bloc resection of colon cancer adherent to other organs. Am J Surg. 1987 Jul;154(1):67-71. doi: 10.1016/0002-9610(87)90292-3.

  PMID: 2440334 BACKGROUND

• Govindarajan A, Coburn NG, Kiss A, Rabeneck L, Smith AJ, Law CH. Population-based assessment of the surgical management of locally advanced colorectal cancer. J Natl Cancer Inst. 2006 Oct 18;98(20):1474-81. doi: 10.1093/jnci/djj396.

  PMID: 17047196 BACKGROUND

• Leijssen LGJ, Dinaux AM, Amri R, Kunitake H, Bordeianou LG, Berger DL. The Impact of a Multivisceral Resection and Adjuvant Therapy in Locally Advanced Colon Cancer. J Gastrointest Surg. 2019 Feb;23(2):357-366. doi: 10.1007/s11605-018-3962-z. Epub 2018 Oct 3.

  PMID: 30284199 BACKGROUND

• Law WL, Chu KW, Choi HK. Total pelvic exenteration for locally advanced rectal cancer. J Am Coll Surg. 2000 Jan;190(1):78-83. doi: 10.1016/s1072-7515(99)00229-x.

  PMID: 10625236 BACKGROUND

• Hoppe RT, Advani RH, Ai WZ, Ambinder RF, Aoun P, Bello CM, Benitez CM, Bernat K, Bierman PJ, Blum KA, Chen R, Dabaja B, Forero A, Gordon LI, Hernandez-Ilizaliturri FJ, Hochberg EP, Huang J, Johnston PB, Kaminski MS, Kenkre VP, Khan N, Maloney DG, Mauch PM, Metzger M, Moore JO, Morgan D, Moskowitz CH, Mulroney C, Poppe M, Rabinovitch R, Seropian S, Smith M, Winter JN, Yahalom J, Burns J, Ogba N, Sundar H. Hodgkin Lymphoma Version 1.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 May;15(5):608-638. doi: 10.6004/jnccn.2017.0064.

  PMID: 28476741 BACKGROUND

• Amri R, Bordeianou LG, Sylla P, Berger DL. Association of Radial Margin Positivity With Colon Cancer. JAMA Surg. 2015 Sep;150(9):890-8. doi: 10.1001/jamasurg.2015.1525.

  PMID: 26132363 BACKGROUND

• Klaver CEL, Kappen TM, Borstlap WAA, Bemelman WA, Tanis PJ. Laparoscopic surgery for T4 colon cancer: a systematic review and meta-analysis. Surg Endosc. 2017 Dec;31(12):4902-4912. doi: 10.1007/s00464-017-5544-7. Epub 2017 Apr 21.

  PMID: 28432461 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

  PMID: 25220842 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dirigente Medico I livello Chirurgia Generale

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 30, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2021
• Study Completion: June 30, 2021
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share