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Trial record 63 of 297 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

Brief Summary:
Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Capecitabine Other: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maintenance Chemotherapy for Metastatic Colorectal Carcinoma
Estimated Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo
Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
Other: placebo
14 days

Experimental: Capecitabine
Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days
Drug: Capecitabine
14days




Primary Outcome Measures :
  1. DDC:Duration of Disease Control [ Time Frame: 2 years ]
    progression-free survival of first-line chemotherapy with second-line chemotherapy


Secondary Outcome Measures :
  1. OS:Overall Survival [ Time Frame: 2 years ]
    measured from the initiation of chemotherapy to the date of the last follow-up or death

  2. 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.


Other Outcome Measures:
  1. Safety [ Time Frame: 2 years ]
    Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.



Information from the National Library of Medicine

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

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


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): NCT02043821


Contacts
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Contact: Dong Yan, PhD 13621308215 yd15yt88@163.com

Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Study Director: Guangyu An, PhD Beijing Chao Yang Hospital

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Responsible Party: Dong Yan, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02043821     History of Changes
Other Study ID Numbers: 20140116
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents