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Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

NCT03125980 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1370

Last updated 2017-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Locally Advanced Colon Cancer

Interventions

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)

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2022-05-31
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125980 on ClinicalTrials.gov