Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

April 19, 2017 updated by: Sanjun Cai, Fudan University

Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial

Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1370

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Colorectal Surgery Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
  • Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109/L, Platelet count≥100×109/L, Hemoglobin≥80g/L, Serum bilirubin≤24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60×IU/L, Serum creatinine≤110 umol/L;
  • No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception ;
  • Be in a condition to receive a surgery/procedure;
  • No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
  • No previous systemic chemotherapy for treating colon cancer;
  • No other chemotherapy at the same time;
  • Expected lifetime longer than three months;
  • Be willing and able to understand the study and to provide written informed consent.

Exclusion Criteria:

  • End-stage cachexia patients;
  • Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;
  • Metastatic carcinoma;
  • Moderate or above anemia caused by serious local tumor bleeding;
  • Incomplete or complete intestinal obstruction;
  • Known to be allergic to oxaliplatin or capecitabine;
  • Active hepatitis, severe coagulation disorder patients;
  • Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
  • Known to have deficient dihydropyrimidine dehydrogenase (DPD)；
  • Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric history；severe infection; active disseminated intravascular coagulation;
  • Unable or unwilling to abide by the study plan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perioperative chemotherapy with CapOX regimen
Drug: capecitabine plus oxaliplatin before and after surgery

Subjects will receive systemic CapeOX chemotherapy both before and after the radical surgery for at most 4 cycles respectively. They shall have rest after the surgery for at least four weeks before the post-operative chemotherapy. CapOX regimen will be administered as follows:

  1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
  2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
  3. Repeat every 3 weeks (Q3W)
Active Comparator: Postoperative chemotherapy with CapOX regimen
Drug: capecitabine plus oxaliplatin after surgery

Subjects will first receive radical surgery, then have rest for at least four weeks. Thereafter, subjects will receive systemic CapeOX chemotherapy for at most 8 cycles. CapOX regimen will be administered as follows:

  1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
  2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
  3. Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease free survival
Time Frame: 3 years
Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: From the date of randomization until the date of the last patient receiving surgery, assessed up to 40 months
Defined as the rate of patients whose tumors are completely resected with all the margins being negative
From the date of randomization until the date of the last patient receiving surgery, assessed up to 40 months
Post-operative TRG staging
Time Frame: From the date of randomization until the date of the last patients receiving surgery, assessed up to 40 months
Defined as the TRG staging of tumor after surgery
From the date of randomization until the date of the last patients receiving surgery, assessed up to 40 months
Overall survival (OS)
Time Frame: 5 years
Defined as the length of time from randomization date until the date of death from any cause
5 years
Relapse-free survival (RFS)
Time Frame: 5 years
Defined as the length of time from the date of randomization until the first documented date of relapse.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Director: Ye Xu, M.D, Department of Colorectal Surgery Fudan University Shanghai Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2027

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CapeOXcc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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