Colorectal Neoplasms Clinical Trial
Official title:
Maintenance Treatment With Capecitabine Versus Observation After First Line Chemotherapy in Patients With Metastatic Colorectal Cancer: a Randomized Phase II Study
Verified date | January 2014 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 245 |
Est. completion date | June 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Medical Oncology,Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Li YH, Luo HY, Wang FH, Wang ZQ, Qiu MZ, Shi YX, Xiang XJ, Chen XQ, He YJ, Xu RH. Phase II study of capecitabine plus oxaliplatin (XELOX) as first-line treatment and followed by maintenance of capecitabine in patients with metastatic colorectal cancer. J — View Citation
Waddell T, Gollins S, Soe W, Valle J, Allen J, Bentley D, Morris J, Lloyd A, Swindell R, Taylor MB, Saunders MP. Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progression-free survival (PFS) | defined as the interval between initial treatment and the first documentation of disease progression or death | up to 30 months | No |
Secondary | overall survival (OS) | measured from the initiation of chemotherapy to the date of the last follow-up or death | up to 3 years | No |
Secondary | overall response(ORR) | 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. | up to 9 months | No |
Secondary | Safety | Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4. | 3 years | Yes |
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