Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV
OBJECTIVES Primary evaluate the disease free survival rate of three years in patients with
stage IIIC or resectable stage IV colorectal cancer treated with maintenance capecitabine.
1. Evaluate the over all survival time in patients treated with these regimens.
2. Correlate genetic patterns and the presence or absence of specific tissue biomarkers
with response and prognosis in patients treated with these regimens.
3. Determine quality of life (QOL) of patients treated with maintenance capecitabine
versus chemotherapy termination.
4. Determine the toxic effects of maintenance regimens in these patients.
5. Determine the convenience of care in patients treated with maintenance regimens.
OUTLINE: This is a single arm, single-enter study. Patients are receiving therapies as
Patients undergo R0-R1 resection and receive adjuvant chemotherapy oxaliplatin with
fluorouracil (5FU) and folinic acid（FOLFOX）or oxaliplatin with oxaliplatin with
capecitabine(capox) for no less than 4 months. Radiotherapy may be applied for patients with
rectal cancer if clinicians suspect that is necessary. Then patients receive oral
capecitabine for 12 months maintenance.
Quality of life is assessed at completion of adjuvant treatment, at completion of
maintenance chemotherapy , and at 1 year after maintenance chemotherapy.
After completion of adjuvant treatment, patients are followed every 3 months for 2 years,
and then every 6 months for 3years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Eligibility Ages Eligible for Study: 18-80 Years old Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free Survival rate(DFS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Yanhong Deng, MD
The sixth affiliated hospital of Sun Yat-sen University
China: Food and Drug Administration