Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer — CAMCO  

Colorectal Neoplasms Clinical Trial

Official title: Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV

Status Recruiting

Clinical Trial Summary

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy with capecitabine is still unknown.

PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy followed by maintenance therapy with capecitabine to see the efficacy and safety, then to investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV colorectal cancer.

Clinical Trial Description

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.

Secondary

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 below.

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 ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

• NCT number: NCT01880658
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Yanhong Deng, MD
• Phone: 008613925106525
• Email: 13925106525@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2013
• Completion date: May 2019