Perioperative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis

NCT02912052 | Unknown Phase 3 DMC

• 1 other identifier: SYM20160908
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective Randomized Clinical Trial to investigate the Effect ofPeri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis

Conditions

Colon Cancer

Keywords

Perioperative Chemotherapy; Postoperative Chemotherapy; Colon Cancer; Resectable Liver Metastasis

Outcome Measures

Primary Outcomes (1)

• Disease free survival，DFS

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Other Outcomes (6)

• recurrence-free survival

  5 years

• local recurrence rate

  5 years

• length of postoperative hospital stay

  30 days

Study Arms (2)

Peri-operative chemotherapy

EXPERIMENTAL

Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.

Drug: Peri-operative chemotherapy

postoperative chemotherapy

ACTIVE COMPARATOR

Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.

Drug: postoperative chemotherapy

Interventions

Peri-operative chemotherapy DRUG

Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)

Also known as: XELOX

Peri-operative chemotherapy

postoperative chemotherapy DRUG

Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)

Also known as: XELOX

postoperative chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) 18-80 years old, patients with synchronous liver metastatic colorectal cancer confirmed by pathology diagnosis(2) ASA score: I-III (3) MDT evaluation: primary tumor can be cut, liver metastases can get complete resection at R0 level. The adjacent Hepatic segments have enough blood flow to be shared and retain sufficient liver function, liver residual volume is larger than or equal to 50%; general condition of the patient is good enough, without extrahepatic unresectable metastasis, and can tolerate systemic chemotherapy. (4) there are evaluating lesions according to the RESIST 1 edition: at least the single path of the lesions can be accurately measured, and the maximum diameter of the conventional techniques (traditional physical examination, CT, X, MRI) ≥20mm CT≥10mm or spiral (5) within 3 weeks before entering the group , the laboratory test index and evaluation of the disease show good bone marrow, liver and kidney function reserve: 1) bone marrow function : Hb ≥ 90 g/L, neutrophil absolute value is more than 1.5 x 109/L, the platelet count was larger than 80 x 109/L; 2) renal function: serum creatinine \< 1.5 x ULN or the creatinine clearance rate≥ 50 mL/min; 3) liver function: AST and ALT ≤2.5 \*ULN(if the disease is caused by tumor, AST and ALT≤5 \*ULN, hemobilirubin ≤2 \*ULN. (6) signed the informed consent.

You may not qualify if:

• (1) the pathological diagnosis is not adenocarcinoma or multiform pathological types. (2)with clinical symptoms requiring emergency surgery for treatment (complete obstruction, bleeding, intestinal perforation). (3) have received chemotherapy treatment or combined with other the anti-tumor treatment. (4) with serious basic diseases: heart disease, kidney failure, severe liver dysfunction or liver failure, coagulation dysfunction or oral dose of anticoagulant drugs, a baseline proteinuria (total urine protein \>1g/d). (5) any other contraindications for the use of chemotherapy treatment (6) patients with pregnancy (7)with previous or existing central nervous system metastasis. (8) there have been cerebrovascular accident or stroke in the past 12 months (9) any other drugs may affect safety or surgical operation history (10) multiple primary colon cancer patients, or suffer from other malignant tumors, or have been systematic chemotherapy (11) with neurological or psychiatric disorders affecting cognitive ability (12)patients cannot accept the treatment because of the psychological, family or social reasons(13) patients with liver metastasis get complete remission after preoperative chemotherapy(14)patients with severe postoperative complications cannot do chemotherapy within the prescribed time (15)liver metastases cannot get hameochronous and R0 standard resection.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu province hospital

Nanjing, Jiangsu, 210029, China

Location

Related Publications (11)

• Wang ZM, Chen YY, Chen FF, Wang SY, Xiong B. Peri-operative chemotherapy for patients with resectable colorectal hepatic metastasis: A meta-analysis. Eur J Surg Oncol. 2015 Sep;41(9):1197-203. doi: 10.1016/j.ejso.2015.05.020. Epub 2015 Jun 11.

  PMID: 26094113 BACKGROUND

• Bilchik AJ, Poston G, Adam R, Choti MA. Prognostic variables for resection of colorectal cancer hepatic metastases: an evolving paradigm. J Clin Oncol. 2008 Nov 20;26(33):5320-1. doi: 10.1200/JCO.2008.18.3152. Epub 2008 Oct 20. No abstract available.

  PMID: 18936470 BACKGROUND

• Portier G, Elias D, Bouche O, Rougier P, Bosset JF, Saric J, Belghiti J, Piedbois P, Guimbaud R, Nordlinger B, Bugat R, Lazorthes F, Bedenne L. Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial. J Clin Oncol. 2006 Nov 1;24(31):4976-82. doi: 10.1200/JCO.2006.06.8353.

  PMID: 17075115 BACKGROUND

• Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.

  PMID: 24120480 BACKGROUND

• Araujo R, Gonen M, Allen P, Blumgart L, DeMatteo R, Fong Y, Kemeny N, Jarnagin W, D'Angelica M. Comparison between perioperative and postoperative chemotherapy after potentially curative hepatic resection for metastatic colorectal cancer. Ann Surg Oncol. 2013 Dec;20(13):4312-21. doi: 10.1245/s10434-013-3162-8. Epub 2013 Jul 30.

  PMID: 23897009 BACKGROUND

• Tamandl D, Gruenberger B, Herberger B, Kaczirek K, Gruenberger T. Surgery after neoadjuvant chemotherapy for colorectal liver metastases is safe and feasible in elderly patients. J Surg Oncol. 2009 Oct 1;100(5):364-71. doi: 10.1002/jso.21259.

  PMID: 19235181 BACKGROUND

• Khoo E, O'Neill S, Brown E, Wigmore SJ, Harrison EM. Systematic review of systemic adjuvant, neoadjuvant and perioperative chemotherapy for resectable colorectal-liver metastases. HPB (Oxford). 2016 Jun;18(6):485-93. doi: 10.1016/j.hpb.2016.03.001. Epub 2016 Apr 20.

  PMID: 27317952 BACKGROUND

• Schmoll HJ, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, Price T, Lim R, Van Cutsem E, Park YS, McKendrick J, Topham C, Soler-Gonzalez G, de Braud F, Hill M, Sirzen F, Haller DG. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol. 2007 Jan 1;25(1):102-9. doi: 10.1200/JCO.2006.08.1075.

  PMID: 17194911 BACKGROUND

• Fong Y, Salo J. Surgical therapy of hepatic colorectal metastasis. Semin Oncol. 1999 Oct;26(5):514-23.

  PMID: 10528899 BACKGROUND

• Muratore A, Zorzi D, Bouzari H, Amisano M, Massucco P, Sperti E, Capussotti L. Asymptomatic colorectal cancer with un-resectable liver metastases: immediate colorectal resection or up-front systemic chemotherapy? Ann Surg Oncol. 2007 Feb;14(2):766-70. doi: 10.1245/s10434-006-9146-1. Epub 2006 Nov 14.

  PMID: 17103261 BACKGROUND

• Fong Y, Cohen AM, Fortner JG, Enker WE, Turnbull AD, Coit DG, Marrero AM, Prasad M, Blumgart LH, Brennan MF. Liver resection for colorectal metastases. J Clin Oncol. 1997 Mar;15(3):938-46. doi: 10.1200/JCO.1997.15.3.938.

  PMID: 9060531 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Fumin Zhang, PHD

  Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

  STUDY DIRECTOR

Central Study Contacts

Yueming Sun, PHD

CONTACT

02568136026; jssym@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

CN (1)