CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

Trial Title: CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

NCT ID: NCT05699746

Condition: Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms
Capecitabine
Oxaliplatin

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Capecitabine tablets
Description: Capecitabine 1000 mg/m2, twice daily PO for 14 days, repeat every 3 weeks, for at most 8 cycles.
Arm group label: CAPEOX

Intervention type: Drug
Intervention name: Oxaliplatin
Description: Oxaliplatin 130 mg/m2 IV day 1, combined with Capecitabine, for at most 8 cycles.
Arm group label: CAPEOX

Summary: Patients with stage Ⅰ colorectal cancer or stage Ⅱ colon cancer usually have a good prognosis and are not recommended to receive adjuvant chemotherapy after radical surgery. With the advances in liquid biopsy technology, detection of circulating tumor DNA (ctDNA) can effectively identify early-stage cancer patients with minimal residual disease (MRD) after surgery. According to the growing number of MRD studies in solid tumor, colorectal cancer patients with ctDNA-MRD detection have a poor clinical outcome and are likely to relapse within two years. This study aims to assess the efficacy of adjuvant chemotherapy with capecitabine plus oxaliplatin (CAPEOX) compared with conventional observation in MRD-positive patients with stage I colorectal cancer and clinically low-risk stage II colon cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Colorectal cancer confirmed by pathology, and the TNM stage (AJCC v8) is stage I or stage II. Stage II patients have T3 colonic adenocarcinoma with proficient mismatch-repair system (by immunohistochemistry for four mismatch repair proteins MSH1, MSH2, MSH6, and PMS2) and have no the following clinical risk factors: a) less than 12 lymph nodes examined; b) mucinous carcinoma; c) poor differentiation; d) bowel obstruction or perforation; e) lymphatic/vascular invasion, perineural invasion; f) close, indeterminate, uncertain, positive margins 2. ECOG performance status 0-1 3. No neoadjuvant therapy before surgery 4. Appropriate for active surveillance (i.e., no adjuvant chemotherapy) based on current practice patterns or according to the Chinese Society of Clinical Oncology guidelines for Colorectal Cancer (version 2022) 5. No history of other primary cancers in the past 3 years 6. No history of bone marrow, stem cell or organ transplant 7. Blood samples from 7 to 21 days after surgery were tested positive for ctDNA (tested by MinerVa MRD assay) 8. Pregnancy test done within 14 days before randomization must be negative (for women of childbearing potential only) 9. Voluntarily join the study and sign the informed consent document 10. No unstable or any medical condition that affects patient safety and study compliance evaluated by researchers 11. Availability and provision of adequate surgical tumor tissue for molecular diagnostics Exclusion Criteria: 1. Patients with multiple primary colorectal cancers 2. Patients with another primary cancer 3. Patients have the following conditions by blood test, or have obvious contraindication in adjuvant chemotherapy: 1. Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation 2. Absolute neutrophil count <1.5×109/L 3. Platelet count < 75×109/L 4. Hemoglobin <90 g/L 5. Aspartate aminotransferase/Alanine aminotransferase >2.5 × upper limit of normal 4. Lactating women 5. Have serious or uncontrolled medical condition that may preclude compliance with the protocol

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Changhai Hospital of Shanghai

Address:
City: Shanghai
Zip: 200433
Country: China

Facility:
Name: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: Second Affiliated Hospital Zhejiang University College of Medicine

Address:
City: Hangzhou
Zip: 310999
Country: China

Contact:
Last name: Ke-Feng Ding, phD/MD

Phone: 86-571-87784827
Email: dingkefeng@zju.edu.cn

Investigator:
Last name: Ke-Feng Ding, phD/MD
Email: Principal Investigator

Facility:
Name: The second hospital of Ningbo City

Address:
City: Ningbo
Zip: 315010
Country: China

Start date: March 2023

Completion date: December 2026

Lead sponsor:
Agency: Zhejiang University
Agency class: Other

Collaborator:
Agency: GeneCast Biotechnology Co., Ltd.
Agency class: Industry

Source: Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05699746