NCT01972503

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

5.3 years

First QC Date

September 23, 2013

Last Update Submit

December 10, 2013

Conditions

Colorectal NeoplasmsNeoplasm MetastasisLiver Neoplasms

Keywords

Colorectal NeoplasmsLiverNeoplasm MetastasisTegafuroxaliplatin

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years after operation

Secondary Outcomes (1)

  • 3 years overall survival and metastasis-free survival

    3 years after operation

Study Arms (2)

ARM A

EXPERIMENTAL

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.

Drug: 5-FU and oxaliplatinProcedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)

ARM B

ACTIVE COMPARATOR

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.

Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)

Interventions

5-FU and oxaliplatinDRUG

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 A
colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)PROCEDURE

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).

ARM AARM B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • has prior other malignant cancer
  • has severe major organ dysfunction
  • has prior cancer therapy before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26465781DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisLiver Neoplasms

Interventions

FluorouracilOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Central Study Contacts

jianmin Xu, PHD

CONTACT

008613501984869xujmin@aliyun.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Jianmin Xu, PhD Fudan University

Study Record Dates

First Submitted

September 23, 2013

First Posted

October 30, 2013

Study Start

June 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2015

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

CN(1)