Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Evaluate the over all survival time in patients treated with these regimens. Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens. Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination. Determine the toxic effects of maintenance regimens in these patients. 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

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

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Adenocarcinoma of the colon or rectum Age:18-80 years old Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected) Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months 5.15 days prior recruit, meet the following criteria: Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Total bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN Aspartate transaminase ≤ 2.5 times ULN Alanine transaminase ≤ 2.5 times ULN No hepatic disease that would preclude study treatment or follow-up No uncontrolled coagulopathy Renal Creatinine clearance > 50 mL/min No renal disease that would preclude study treatment or follow-up 6.The ECOG scores: 0～1 Exclusion Criteria: Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma) Synchronous cancer of other site Hypersensitivity to capecitabine No More than 4 weeks since prior participation in any investigational drug study Clear indication of involvement of the pelvic side walls by imaging With distant metastasis History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception Uncontrolled hypertension Cardiovascular disease that would preclude study treatment or follow-up Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding Pregnant or nursing, Fertile patients do not use effective contraception Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Patients undergo R0-R1 resection and receive adjuvant chemotherapy FOLFOX or 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. | Drug: Capecitabine<br>* Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over all survival,genetic patterns, quality of life, toxic effects, convenience | Evaluate the over all survival time in patients treated with these regimens. Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens. Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination. Determine the toxic effects of maintenance regimens in these patients. Determine the convenience of care in patients treated with maintenance regimens. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maintenance therapy, Capecitabine, Adjuvant chemotherapy, Post-operation