Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

April 6, 2020 updated by: Qi Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Adjuvant Chemotherapy Versus Observation in Stage II Colon Cancer Patients With High-Risk Factors and High-Immunoscore®

  • Benefit of adjuvant chemotherapy after curative surgery for stage II Colon Cancer is still debated. Several high-risk features may help to stratify stage II cancer patients into groups that will truly benefit from adjuvant chemotherapy. However, those factors are rather subjective, and no specific trial has been designed to answer the high-risk stage II colon cancer question directly.
  • Immunoscore® Colon, an in vitro diagnostic test, which quantifies the density of CD3+ and CD8+ T lymphocyte populations in the center the tumor (CT) and its invasive margin (IM) using immunohistochemistry and automated image analysis. Immunoscore® has been extensively validated as a prognostic biomarker in early stage CC patients. This unique diagnostic assay measuring host immune response at the tumor site may inform the decision to administer adjuvant chemotherapy in resected Stage II and III CC patients.
  • This randomized trial is studying how observation compares to adjuvant chemotherapy (investigator's choice) in stage II colon cancer patients with high-risk features and High-Immunoscore®. The trial would represent a unique opportunity to classify stage II CC patients based on their tumor microenvironment with the aim to provide efficient patient stratification to improve clinical care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

962

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Haiyan Zhang, MD
  • Phone Number: +8613611956117
  • Email: Zhymmx@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-75 years old
  2. Pathologically confirmed adenocarcinoma of the colon
  3. Complete resection of the primary tumor without gross or microscopic evidence of residual disease
  4. Histologically proven stage II: T3-T4 N0
  5. At least one of the following factors:T4 staging,Number of examined lymph nodes < 12,poor differentiation (except MSI-H),LVI or PNI,tumor perforation or occlusion
  6. Treatment within 7 weeks following surgery
  7. ECOG PS 0-1
  8. No prior chemo, immuno or radiotherapy
  9. Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion criteria

  1. Have a birth plan during the clinical trial;
  2. Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;
  3. Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;
  4. Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;
  5. Allergy or hypersensitivity history of the drug or drug ingredient used in this test;
  6. Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;
  7. Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
  8. The investigator believes that it is not suitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: observation group
Patients enrolled in the observation group will not receive any chemotherapy drugs
Experimental: adjuvant chemotherapy group
Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.
Drug: FOLFOX/XELOX/Capecitabine
Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: 3 years
To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of disease free survival (DFS).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recurrence (TTR)
Time Frame: From date of enrollment until the date of recurrence,assessed 1year,3years and 5years after therapy
To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of Time To Recurrence (TTR)
From date of enrollment until the date of recurrence,assessed 1year,3years and 5years after therapy
Overall Survival (OS)
Time Frame: From date of enrollment until the date of death,assessed 1year,3years and 5years after therapy
To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of overall survival (OS)
From date of enrollment until the date of death,assessed 1year,3years and 5years after therapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost Utility Analysis
Time Frame: through study completion,an average of 3 years
An cost utility analysis at the country level will be conducted alongside the clinical evaluation (exploratory)
through study completion,an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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