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Trial record 6 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Maintenance Treatment With Capecitabine in Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02027363
Recruitment Status : Unknown
Verified January 2014 by Ruihua Xu, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE December 15, 2013
First Posted Date  ICMJE January 6, 2014
Last Update Posted Date January 6, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
progression-free survival (PFS) [ Time Frame: up to 30 months ]
defined as the interval between initial treatment and the first documentation of disease progression or death
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • overall survival (OS) [ Time Frame: up to 3 years ]
    measured from the initiation of chemotherapy to the date of the last follow-up or death
  • overall response(ORR) [ Time Frame: up to 9 months ]
    Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.
  • Safety [ Time Frame: 3 years ]
    Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.
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 Maintenance Treatment With Capecitabine in Colorectal Cancer Patients
Official Title  ICMJE Maintenance Treatment With Capecitabine Versus Observation After First Line Chemotherapy in Patients With Metastatic Colorectal Cancer: a Randomized Phase II Study
Brief Summary

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.

5-Fluorouracil(5-FU) was the only efficacious treatment for metastatic colorectal cancer before the nineties of the 20th century, and afterwards as the discovery of chemotherapy such as oxaliplatin, irinotecan and capecitabine, response rate as well as survival had been improved greatly.

Most of advanced colorectal cancer will progress after first-line treatment; therefore, seeking an efficient and low toxic maintaining regimen to prolong PFS becomes a hot topic in oncologic field. Some clinical researches demonstrated that maintaining treatment followed first-line treating advanced NSCLC could extend PFS and OS. In metastatic colorectal cancer, patients receiving 5-FU/leucovorin(LV) maintaining therapy experienced significantly longer PFS than that stopped chemotherapy after six cycles of FOLFOX4 in OPTIMOX2 study. One phase II study shown that median PFS was 13.9 months, and median OS was 31 months in 30 patients receiving first-line treatment of six- month FOLFOX4 followed by UFT as maintaining treatment . A non-randomized small sample study conducted in department of medical oncology of Sun Yat-Sen University Cancer Center indicated that patients receiving first-line treatment of XELOX followed by capecitabine as maintaining therapy has significantly prolonged median TTP, comparing with the non-maintaining treatment patients,(14months vs. 9 month, respectively).

Above all, so far, there is no data to demonstrate that regular 4-6 month chemotherapy followed by maintaining treatment could prolong TTP and OS for advanced colorectal cancer. Capecitabine is effective for colorectal cancer, and was approved as palliative treatment for advanced colorectal cancer and adjuvant chemotherapy; in addition, with its relative less frequency of side effects and convenient oral administration, capecitabine as maintaining regimen could be prone to be accepted by patients. Therefore, our study is designed to investigate that capecitabine as maintaining treatment after first-line palliative chemotherapy could improve TTP and OS for patients with advanced colorectal cancer through a perspective randomized clinical study.

Detailed Description Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy were randomly assigned to one of two groups, to receive either capecitabine (2000 mg/m2 per day on days 1-14,Q3W) as maintenance therapy or observation. The treatment will continue until disease progression or unacceptable toxicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Neoplasms Metastasis
Intervention  ICMJE
  • Drug: Capecitabine
    maintenance with apecitabine,1,000 mg/m2 twice a day, days1-15,every 3 weeks,until progression, unacceptable toxicity, or patient withdrawal.
    Other Name: Capecitabine (XELODA ,Roche)
  • Other: Observation
    Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy would stop the chemotherapy and observation
Study Arms  ICMJE
  • Experimental: Observation group
    Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy would stop the chemotherapy and observation.
    Intervention: Other: Observation
  • Experimental: Capecitabine group

    Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy could continue to receive oral capecitabine as maintenance therapy, capecitabine, 1000mg/m2 bid d1-14, every 3 week.

    The maintenance treatment was continued until progression, unacceptable toxicity, or patient withdrawal.

    Intervention: Drug: Capecitabine
Publications *

*   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 2, 2014)
245
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age older than 18 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, not amenable to curative therapy.
  • Life expectancy of at least 3 months
  • Hematologic, Biochemical and Organ Function 14. Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L. 15. Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN (or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or albumin < 25 g/L
  • Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy
  • Signed informed consent

Exclusion Criteria:

  • Known hypersensitivity to capecitabine
  • History or clinical evidence of brain metastases
  • No previous chemotherapy for metastatic disease
  • Positive serum pregnancy test in women of childbearing potential
  • Subjects with reproductive potential not willing to use an effective method of contraception
  • Received any investigational drug treatment within 4 weeks of start of study treatment
  • other prior malignancies in the past 5 years
  • 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02027363
Other Study ID Numbers  ICMJE Maintenance study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ruihua Xu, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruihua Xu, M.D,Ph.D Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date January 2014

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