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.|
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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)
- 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
- 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.
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): NCT02027363
|Medical Oncology,Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Ruihua Xu, M.D,Ph.D||Sun Yat-sen University|