Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

NCT ID: NCT04303429

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 962 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2025-01-31

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.

Conditions

Stage II Colon Cancer; Adjuvant Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

observation group

Patients enrolled in the observation group will not receive any chemotherapy drugs

Group Type: NO_INTERVENTION

No interventions assigned to this group

adjuvant chemotherapy group

Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.

Group Type: EXPERIMENTAL

FOLFOX/XELOX/Capecitabine

Intervention Type: DRUG

Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.

Interventions

FOLFOX/XELOX/Capecitabine

Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qi Li

Executive director of cancer center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

qi li, MD,PhD

Role: CONTACT

Leeqi2001@hotmail.com

+8613818207333

Haiyan Zhang, MD

Role: CONTACT

Zhymmx@sina.com

+8613611956117

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Other Identifiers

IMCC

Identifier Type: -

Identifier Source: org_study_id