Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety

NCT01465451 | Unknown Phase 3 DMC

• 1 other identifier: SYSU 5010-2010016 IOCCRC
• Study Type: interventional
• Target: 695
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; curative resection; intra-operative chemotherapy; 5-fluorouracil; chemotherapy

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  3 years survival of recurrence-free, metastasisi-free, death-free after randomization.

  3 years

Secondary Outcomes (2)

• disease-free survival

  5 years

• safety profiles

  28 days after randomization

Study Arms (2)

ARM A- surgery alone

ACTIVE COMPARATOR

all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.

Procedure: curative resection for colorectal cancer

ARM B surgery plus chemotherapy

EXPERIMENTAL

all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.

Procedure: curative resection for colorectal cancer; Drug: intra-operative 5-FU chemotherapy

Interventions

curative resection for colorectal cancer PROCEDURE

right hemicolectomy for right colon cancer, transverse colectomy for transverse colon cancer, left hemicolectomy for left colon cancer, sigmoid colectomy for sigmoid colon cancer, and anterior resection or abdominal-perineal resection for rectal cancer.

Also known as: curative resection for colorectal cancer.

ARM A- surgery alone; ARM B surgery plus chemotherapy

intra-operative 5-FU chemotherapy DRUG

5-FU, 1000 mg/m2, injection into bowel lumen at the beginning of resection 5-FU, 200 mg/m2, injection into portal vein via mesentery vein at the end of tumor removal and bowel reconstruction. 5-FU, 300 mg/m2, left in abdominal cavity before incision closure. surgical procedures will be the same as described in ARM A.

Also known as: intra-operative 5-FU chemotherapy for colorectal cancer

ARM B surgery plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed as adenocarcinoma of colon and rectum
• age 18-75 years
• eligible for curative surgical resection
• performance score: ECOG 0-1
• normal blood cells counts: WBC ≥ 4.0×10\*9/L，PLT ≥ 100×10\*9/L
• normal blood chemistry test: ALT/AST ≤ 2.5 ULN, TBil ≤ 1.5 ULN, BUN ≤ 1.5 ULN,Cr ≤ 1.5 ULN
• normal ECG
• no history of other malignant tumors
• no concomitant anti-cancer therapy

You may not qualify if:

• clinical bowel obstruction
• anticipated into another clinical trial within three months
• uncontrolled infection, serious internal medical diseases
• Pregnant or lactating women
• mentally abnormal patients
• patients known allergic to 5-FU

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Zhang RX, Lin JZ, Lei J, Chen G, Li LR, Lu ZH, Ding PR, Huang JQ, Kong LH, Wang FL, Li C, Jiang W, Ke CF, Zhou WH, Fan WH, Liu Q, Wan DS, Wu XJ, Pan ZZ. Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC). J Cancer Res Clin Oncol. 2017 Dec;143(12):2581-2593. doi: 10.1007/s00432-017-2489-0. Epub 2017 Aug 28.

  PMID: 28849265 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• zhizhong pan, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director, M.D., Ph.D

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 4, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

CN (1)