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CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

Primary Purpose

Colorectal Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Capecitabine tablets
Oxaliplatin
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Changhai Hospital of Shanghai
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Second Affiliated Hospital Zhejiang University College of Medicine
  • The second hospital of Ningbo City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CAPEOX

Observation

Arm Description

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.

Patients undergo active surveillance

Outcomes

Primary Outcome Measures

Recurrence-free survival

Secondary Outcome Measures

Clearance of circulating tumor DNA (ctDNA)

Full Information

First Posted
January 16, 2023
Last Updated
January 16, 2023
Sponsor
Zhejiang University
Collaborators
GeneCast Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05699746
Brief Title
CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD
Official Title
A Randomized Controlled Trial of CAPEOX vs Observation in Early-stage Colorectal Cancer Patients With Positive MRD After Curative Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
GeneCast Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAPEOX
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Patients undergo active surveillance
Intervention Type
Drug
Intervention Name(s)
Capecitabine tablets
Intervention Description
Capecitabine 1000 mg/m2, twice daily PO for 14 days, repeat every 3 weeks, for at most 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 130 mg/m2 IV day 1, combined with Capecitabine, for at most 8 cycles.
Primary Outcome Measure Information:
Title
Recurrence-free survival
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Clearance of circulating tumor DNA (ctDNA)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kefeng Ding, MD, PhD
Phone
+8687784720
Email
dingkefeng@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Xiao, MD, PhD
Email
qxiao3@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kefeng Ding, MD, PhD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Second Affiliated Hospital Zhejiang University College of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310999
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke-Feng Ding, phD/MD
Phone
86-571-87784827
Email
dingkefeng@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Ke-Feng Ding, phD/MD
Facility Name
The second hospital of Ningbo City
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

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