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Trial record 64 of 300 for:    colon cancer AND Capecitabine AND chemotherapy

Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02043821
Recruitment Status : Unknown
Verified January 2014 by Dong Yan, Beijing Chao Yang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2014
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
Dong Yan, Beijing Chao Yang Hospital

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE January 23, 2014
Last Update Posted Date January 24, 2014
Study Start Date  ICMJE Not Provided
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
DDC:Duration of Disease Control [ Time Frame: 2 years ]
progression-free survival of first-line chemotherapy with second-line chemotherapy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02043821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
  • OS:Overall Survival [ Time Frame: 2 years ]
    measured from the initiation of chemotherapy to the date of the last follow-up or death
  • DCR:Disease Control Rate [ Time Frame: 2 years ]
    This is defined as the occurrence of either a confirmed complete (CR),a partial response(PR)or stable disease(SD) as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 21, 2014)
Safety [ Time Frame: 2 years ]
Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker
Official Title  ICMJE Maintenance Chemotherapy for Metastatic Colorectal Carcinoma
Brief Summary Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
Detailed Description Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: Capecitabine
    14days
  • Other: placebo
    14 days
Study Arms  ICMJE
  • Placebo
    Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
    Intervention: Other: placebo
  • Experimental: Capecitabine
    Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days
    Intervention: Drug: Capecitabine
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 21, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL).

Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent

Exclusion Criteria:

- Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome

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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02043821
Other Study ID Numbers  ICMJE 20140116
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong Yan, Beijing Chao Yang Hospital
Study Sponsor  ICMJE Beijing Chao Yang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Guangyu An, PhD Beijing Chao Yang Hospital
PRS Account Beijing Chao Yang Hospital
Verification Date January 2014

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