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Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

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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

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date April 24, 2017
Estimated Study Start Date  ICMJE May 2017
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • 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
  • 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
  • Overall survival (OS) [ Time Frame: 5 years ]
    Defined as the length of time from randomization date until the date of death from any cause
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer
Official Title  ICMJE Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Colon Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Perioperative chemotherapy with CapOX regimen
    Intervention: Drug: capecitabine plus oxaliplatin before and after surgery
  • Active Comparator: Postoperative chemotherapy with CapOX regimen
    Intervention: Drug: capecitabine plus oxaliplatin after surgery
Publications * Liu F, Tong T, Huang D, Yuan W, Li D, Lin J, Cai S, Xu Y, Chen W, Sun Y, Zhuang J. CapeOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced resectable colon cancer: protocol for a two-period randomised controlled phase III trial. BMJ Open. 2019 Jan 29;9(1):e017637. doi: 10.1136/bmjopen-2017-017637.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2017)
1370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2027
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sanjun Cai, M.D +86-21-64175590 ext 81108 caisanjuncsj@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03125980
Other Study ID Numbers  ICMJE CapeOXcc
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanjun Cai, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ye Xu, M.D Department of Colorectal Surgery Fudan University Shanghai Cancer Center
PRS Account Fudan University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP