Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 72 of 3977 for:    colon cancer AND Colonic Diseases

Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03125980
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sanjun Cai, Fudan University

Brief 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Colon Cancer Drug: capecitabine plus oxaliplatin before and after surgery Drug: capecitabine plus oxaliplatin after surgery Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Overall survival (OS) [ Time Frame: 5 years ]
    Defined as the length of time from randomization date until the date of death from any cause

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125980


Contacts
Layout table for location contacts
Contact: Sanjun Cai, M.D +86-21-64175590 ext 81108 caisanjuncsj@163.com

Locations
Layout table for location information
China, Shanghai
Department of Colorectal Surgery Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Sanjun Cai, M.D    +86-21-64175590 ext 81108    caisanjuncsj@163.com   
Sponsors and Collaborators
Fudan University
Investigators
Layout table for investigator information
Study Director: Ye Xu, M.D Department of Colorectal Surgery Fudan University Shanghai Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanjun Cai, Professor, Chief physician, Fudan University
ClinicalTrials.gov Identifier: NCT03125980     History of Changes
Other Study ID Numbers: CapeOXcc
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents