CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

NCT05699746 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IR2022577
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  18 months

Secondary Outcomes (1)

• Clearance of circulating tumor DNA (ctDNA)

  6 months

Study Arms (2)

CAPEOX

EXPERIMENTAL

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.

Drug: Capecitabine tablets; Drug: Oxaliplatin

Observation

NO INTERVENTION

Patients undergo active surveillance

Interventions

Capecitabine tablets DRUG

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

CAPEOX

Oxaliplatin DRUG

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

CAPEOX

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG performance status 0-1
• No neoadjuvant therapy before surgery
• 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)
• No history of other primary cancers in the past 3 years
• No history of bone marrow, stem cell or organ transplant
• Blood samples from 7 to 21 days after surgery were tested positive for ctDNA (tested by MinerVa MRD assay)
• Pregnancy test done within 14 days before randomization must be negative (for women of childbearing potential only)
• Voluntarily join the study and sign the informed consent document
• No unstable or any medical condition that affects patient safety and study compliance evaluated by researchers
• Availability and provision of adequate surgical tumor tissue for molecular diagnostics

You may not qualify if:

• Patients with multiple primary colorectal cancers
• Patients with another primary cancer
• Patients have the following conditions by blood test, or have obvious contraindication in adjuvant chemotherapy:
• Moderate/severe renal impairment (GFR\<30 ml/min), as calculated by the Cockcroft and Gault equation
• Absolute neutrophil count \<1.5×109/L
• Platelet count \< 75×109/L
• Hemoglobin \<90 g/L
• Aspartate aminotransferase/Alanine aminotransferase \>2.5 × upper limit of normal
• Lactating women
• Have serious or uncontrolled medical condition that may preclude compliance with the protocol

Sponsors & Collaborators

• Zhejiang University: lead
• GeneCast Biotechnology Co., Ltd.: collaborator

Study Sites (4)

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Second Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, Zhejiang, 310999, China

Location

The second hospital of Ningbo City

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Kefeng Ding, MD, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefeng Ding, MD, PhD

CONTACT

+8687784720; dingkefeng@zju.edu.cn

Qian Xiao, MD, PhD

CONTACT

qxiao3@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)