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Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04303429
Collaborator
(none)
962
Enrollment
2
Arms
53
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

  • 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
962 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Adjuvant Chemotherapy Versus Observation in Stage II Colon Cancer Patients With High-Risk Factors and High-Immunoscore®
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Disease Free Survival (DFS) [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).

Secondary Outcome Measures

  1. Time to Recurrence (TTR) [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)

  2. Overall Survival (OS) [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)

Other Outcome Measures

  1. Cost Utility Analysis [through study completion,an average of 3 years]

    An cost utility analysis at the country level will be conducted alongside the clinical evaluation (exploratory)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Qi Li, Executive director of cancer center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT04303429
Other Study ID Numbers:
  • IMCC
First Posted:
Mar 11, 2020
Last Update Posted:
Apr 8, 2020
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qi Li, Executive director of cancer center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Stage II colon cancer
Adjuvant Chemotherapy
High-Risk factors
High-Immunoscore®
Additional relevant MeSH terms:
Colonic Neoplasms
Capecitabine

Study Results

No Results Posted as of Apr 8, 2020