Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety (IOCCRC)
This study is currently recruiting participants.
Verified November 2011 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
ZHI-ZHONG PAN, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01465451
First received: November 1, 2011
Last updated: November 3, 2011
Last verified: November 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Procedure: curative resection for colorectal cancer Drug: intra-operative 5-FU chemotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Sun Yat-sen University:
Primary Outcome Measures:
- disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]3 years survival of recurrence-free, metastasisi-free, death-free after randomization.
Secondary Outcome Measures:
- disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.
- safety profiles [ Time Frame: 28 days after randomization ] [ Designated as safety issue: Yes ]complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications
| Estimated Enrollment: | 1246 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ARM A- surgery alone
all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
|
Procedure: curative resection for colorectal cancer
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.
Other Name: curative resection for colorectal cancer.
|
|
Experimental: ARM B surgery plus chemotherapy
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
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.
Other Name: curative resection for colorectal cancer.
Drug: intra-operative 5-FU chemotherapy
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. Other Name: intra-operative 5-FU chemotherapy for colorectal cancer
|
Detailed Description:
nil.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465451
Contacts
| Contact: xiaojun wu, MD, Ph.D | +86 20 8734 3456 | wuxj@sysucc.org.cn |
| Contact: niu wang | +86 20 8734 3126 | wangniu@sysucc.org.cn |
Locations
| China, Guangdong | |
| Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: niu wang + 86 20 8734 3126 wangniu@sysucc.org.cn | |
| Sub-Investigator: desen wan, MD | |
Sponsors and Collaborators
Sun Yat-sen University
Investigators
| Principal Investigator: | zhizhong pan, MD, PhD | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | ZHI-ZHONG PAN, Professor, Director, M.D., Ph.D, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01465451 History of Changes |
| Other Study ID Numbers: | SYSU 5010-2010016 IOCCRC |
| Study First Received: | November 1, 2011 |
| Last Updated: | November 3, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Sun Yat-sen University:
|
colorectal cancer curative resection intra-operative chemotherapy 5-fluorouracil chemotherapy |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Fluorouracil Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013