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Maintenance Treatment With Capecitabine in Colorectal Cancer Patients

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. 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
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neoplasms Metastasis Drug: Capecitabine Other: Observation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Treatment With Capecitabine Versus Observation After First Line Chemotherapy in Patients With Metastatic Colorectal Cancer: a Randomized Phase II Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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

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.

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)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Safety [ Time Frame: 3 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

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

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 identifier (NCT number): NCT02027363

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China, Guangdong
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Ruihua Xu, M.D,Ph.D Sun Yat-sen University
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ruihua Xu, Sun Yat-sen University cancer center, Sun Yat-sen University Identifier: NCT02027363    
Other Study ID Numbers: Maintenance study
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Keywords provided by Ruihua Xu, Sun Yat-sen University:
Metastasis colorectal cancer
First-line treatment
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents