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Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III

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: NCT01196260
Recruitment Status : Recruiting
First Posted : September 8, 2010
Last Update Posted : February 20, 2018
Sponsor:
Collaborators:
Tianjin Union Medical Center
Beihua University
Chengdu Medical College
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Dake Chu, State Key Laboratory of Cancer Biology

Tracking Information
First Submitted Date  ICMJE September 3, 2010
First Posted Date  ICMJE September 8, 2010
Last Update Posted Date February 20, 2018
Study Start Date  ICMJE January 2004
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2010)
  • To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs [ Time Frame: 7 years ]
  • To determine the relapse of patients with metastatic colorectal cancer received the combination of drugs [ Time Frame: 7 years ]
  • To determine prognosis of patients with metastatic colorectal cancer received the combination of drugs [ Time Frame: 7 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01196260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2010)
To evaluate the time to progression of metastatic colorectal cancer after treatment [ Time Frame: 7 years ]
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 Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III
Official Title  ICMJE Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population
Brief Summary This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer.
Detailed Description This study will examine a new combination of drugs: Capecitabine and Oxaliplatinfor for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer. In the present trial, we will study the combination of these two drugs in patients with colorectal cancer among Chinese population
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Capecitabine and Oxaliplatin
Capecitabine and Oxaliplatin will be under the NSCLC guideline
Other Names:
  • 1220099
  • CDK
Study Arms  ICMJE Experimental: 5-fluorouracil plus oxaliplatin
patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin
Intervention: Drug: Capecitabine and Oxaliplatin
Publications * Not Provided

*   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: October 10, 2014)
8000
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2010)
1000
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must have a histologically proven TNM stage II or III adenocarcinoma of colon or rectum.
  • Patient must received curative surgical with cancer free margin.
  • Patients must have a performance status of 0,1, or 2.
  • Patients must have an absolute neutrophil count of greater than or equal to 1500/ml, platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal or less than the institution's upper limit or normal range.
  • Patients must have fully recovered from any effects of surgery.
  • Patients must provide a signed consent to participate in the study.

Age:

•18 and over

Performance status:

•WHO 0-2

Life expectancy:

•Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 1.5 times ULN

Renal:

•Creatinine clearance greater than 30 mL/min

Cardiovascular:

More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:

  • Cerebrovascular accident
  • Myocardial infarction
  • Unstable angina
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active peptic ulcer or gastrointestinal bleeding within the past year
  • No inflammatory bowel disease
  • No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

Exclusion Criteria:

  • Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
  • Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
  • Patients who have received prior chemotherapy for colorectal cancer except for patients relapsing more than 6 months after completion of adjuvant chemotherapy.
  • History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
  • Unresolved bacterial infection requiring treatment with antibiotics.
  • Pregnant or lactating women may not participate in the study. Women/men of reproductive age group may not participate unless they have agreed to use an effective method of contraception.
  • Patients who have allergy to any of the study drugs.
  • Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
  • Gilbert's disease.
  • Lack of physical integrity of the upper gastrointestinal tract. Inability to swallow tablets or those who have malabsorption syndrome.
  • Other serious concurrent infection
  • Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dake Chu, M.D. 86-29-84774516 chudake@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01196260
Other Study ID Numbers  ICMJE Dake Chu-200401
StateKeyLab ( Registry Identifier: StateKeyLab )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dake Chu, State Key Laboratory of Cancer Biology
Study Sponsor  ICMJE State Key Laboratory of Cancer Biology
Collaborators  ICMJE
  • Tianjin Union Medical Center
  • Beihua University
  • Chengdu Medical College
  • Shanghai Jiao Tong University School of Medicine
Investigators  ICMJE
Principal Investigator: Dake Chu, M.D. Fourth Military Medical University
PRS Account State Key Laboratory of Cancer Biology
Verification Date February 2018

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