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Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer

Primary Purpose

Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
5-FU and oxaliplatin
colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
Sponsored by
Xu jianmin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Liver, Neoplasm Metastasis, Tegafur, oxaliplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum
  2. WHO performance status of 0 or 1
  3. Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan
  4. Written informed consent for participation in the trial.

Exclusion criteria

  1. has prior other malignant cancer
  2. has severe major organ dysfunction
  3. has prior cancer therapy before surgery

Sites / Locations

  • Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARM A

ARM B

Arm Description

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm B, patients accepted curative resection + mFOLFOX6 alone.

Outcomes

Primary Outcome Measures

3 years disease-free survival
PFS will be defined as the period from the first day of CRC resection to the date of disease recurrence or to death.

Secondary Outcome Measures

3 years overall survival and metastasis-free survival

Full Information

First Posted
September 23, 2013
Last Updated
December 10, 2013
Sponsor
Xu jianmin
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1. Study Identification

Unique Protocol Identification Number
NCT01972503
Brief Title
Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer
Official Title
A Prospective,Randomized Control Trial of Intraoperative Intraportal Chemotherapy (5-FU and Oxaliplatin) Combined With Adjuvant Chemotherapy to Prevent Liver Metastasis in Patients Receiving Curative Colorectal Cancer Resection.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xu jianmin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.
Detailed Description
In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms
Keywords
Colorectal Neoplasms, Liver, Neoplasm Metastasis, Tegafur, oxaliplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM A
Arm Type
Experimental
Arm Description
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.
Arm Title
ARM B
Arm Type
Active Comparator
Arm Description
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm B, patients accepted curative resection + mFOLFOX6 alone.
Intervention Type
Drug
Intervention Name(s)
5-FU and oxaliplatin
Intervention Description
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg+ curative resection + mFOLFOX6.
Intervention Type
Procedure
Intervention Name(s)
colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
Intervention Description
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. All patients in both arms accept curative resection of colorectal cancer,and accept standard adjuvant chemotherapy (mFOLFOX6).
Primary Outcome Measure Information:
Title
3 years disease-free survival
Description
PFS will be defined as the period from the first day of CRC resection to the date of disease recurrence or to death.
Time Frame
3 years after operation
Secondary Outcome Measure Information:
Title
3 years overall survival and metastasis-free survival
Time Frame
3 years after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum WHO performance status of 0 or 1 Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan Written informed consent for participation in the trial. Exclusion criteria has prior other malignant cancer has severe major organ dysfunction has prior cancer therapy before surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianmin Xu, PHD
Phone
008613501984869
Email
xujmin@aliyun.com
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianmin Xu, PHD
Phone
008613501984869
Email
xujmin@aliyun.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
26465781
Citation
Chang W, Wei Y, Ren L, Zhong Y, Yu Y, Chen J, Zhu D, Ye L, Qin C, Zhao N, Niu W, Qin X, Xu J. Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer. Ann Surg. 2016 Mar;263(3):434-9. doi: 10.1097/SLA.0000000000001374.
Results Reference
derived

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Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer

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