NCT03199989

Brief Summary

The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.

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
1,254

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_3

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, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

4.2 years

First QC Date

June 4, 2017

Last Update Submit

March 5, 2020

Conditions

Adjuvant Chemotherapy

Keywords

colon canceradjuvant chemotherapyhigh risk

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival

    Disease free survival was defined as the duration after local recurrence or metastasis were found after surgery. Metastasis of any distant organs such as liver, lung, ovary，bone and peritoneum were defined by CT.

    At least 3 years after the last patient enrolled

Secondary Outcomes (4)

  • 3-year overall survival

    At least 3 years after the last patient enrolled

  • Rate of metastasis

    At least 3 years after the last patient enrolled

  • Relationship between high risk factors and survival

    At least 3 years after the last patient enrolled

  • Major adverse events

    At least 1 years after the last patient enrolled

Study Arms (2)

adjuvant chemotherapy group

ACTIVE COMPARATOR

patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy\[CapeOX（Capecitabine+Oxaliplatin）\] by the current guidelines

Drug: CapeOX（Capecitabine+Oxaliplatin）

observation group

EXPERIMENTAL

patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation

Other: Observation

Interventions

CapeOX（Capecitabine+Oxaliplatin）DRUG

Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months

adjuvant chemotherapy group
ObservationOTHER

Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation

observation group

Eligibility Criteria

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

You may qualify if:

  • aged 18 to 75 years;
  • pathologically confirmed adenocarcinoma of the colon
  • after curative resection pathological stage was T3-4N0M0;
  • with at least one of the following factors:
  • T4 staging
  • lymph nodes number less than 12
  • poor differentiation (except MSI-H)
  • LVI or PNI
  • obstruction or perforation
  • Elevated preoperative serum CEA
  • ECOG Performance status 0-1
  • no evidence of distant metastases
  • no preoperative chemotherapy or chemoradiation therapy
  • ANC \> 1.5 cells/mm3, HGB \> 10.0 g/dL, PLT \> 100,000/mm3, total bilirubin ≤ 1.5 xULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
  • Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

You may not qualify if:

  • combined with other cancer
  • Creatinine level greater than 1.5 times the upper limit of normal.
  • Patients who have received preoperative chemotherapy or chemoradiotherapy.
  • Patients with a history of a prior malignancy within the past 5 years.
  • Women who are pregnant or breast-feeding.
  • patients may not complete the whole schedule of chemotherapy
  • Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing cancer hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Aiwen Wu, M.D.

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengju Chen, M.D.

CONTACT

+8613811403082pengjuchen@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a prospertive randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute

Study Record Dates

First Submitted

June 4, 2017

First Posted

June 27, 2017

Study Start

June 1, 2017

Primary Completion

July 31, 2021

Study Completion

July 31, 2024

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)