CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

NCT ID: NCT05699746

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAPEOX

Drug CAPEOX (Oxaliplatin 130 mg/m2 IV day 1, Capecitabine 1000 mg/m2, twice daily PO for 14 days, repeat every 3 weeks) for at most 8 cycles.

Group Type: EXPERIMENTAL

Capecitabine tablets

Intervention Type: DRUG

Capecitabine 1000 mg/m2, twice daily PO for 14 days, repeat every 3 weeks, for at most 8 cycles.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 130 mg/m2 IV day 1, combined with Capecitabine, for at most 8 cycles.

Observation

Patients undergo active surveillance

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Capecitabine tablets

Capecitabine 1000 mg/m2, twice daily PO for 14 days, repeat every 3 weeks, for at most 8 cycles.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 IV day 1, combined with Capecitabine, for at most 8 cycles.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GeneCast Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Ding Ke-Feng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kefeng Ding, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Second Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, Zhejiang, China

The second hospital of Ningbo City

Ningbo, Zhejiang, China

Countries

China

Central Contacts

Kefeng Ding, MD, PhD

Role: CONTACT

dingkefeng@zju.edu.cn

+8687784720

Qian Xiao, MD, PhD

Role: CONTACT

qxiao3@zju.edu.cn

Facility Contacts

Ke-Feng Ding, phD/MD

Role: primary

dingkefeng@zju.edu.cn

86-571-87784827

Other Identifiers

IR2022577

Identifier Type: -

Identifier Source: org_study_id