Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00114231
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the 3-year disease-free survival rate in patients with stage I adenocarcinoma of the rectum treated with neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and radiotherapy followed by local excision.
Secondary
* Determine the rate of resectability with negative resection margins in patients treated with this regimen.
* Determine the procedure-specific morbidity and mortality in patients treated with this regimen.
* Determine the rate of pathologic complete response of the primary tumor in patients treated with this regimen.
* Determine the impact of this regimen on anorectal function and quality of life in these patients.
* Determine the feasibility of using molecular studies to assess surgical resection margins and tumor response in patients treated with this regimen.
* Determine molecular markers associated with local tumor recurrence in patients treated with this regimen.
OUTLINE: This is a non-randomized, multicenter study.
Patients undergo high-dose external beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oral capecitabine twice daily on days 1-14 and 22-35 and oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
Quality of life is assessed at baseline and then 1 year after surgery.
After completion of study treatment, patients are followed at 1 month, every 4 months for 3 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within 2.8 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) capecitabine Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician. Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) neoadjuvant therapy Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician. Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) radiation therapy Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician. Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) oxaliplatin Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
- Primary Outcome Measures
Name Time Method 3-Year Disease-free Survival Up to 3 years The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.
- Secondary Outcome Measures
Name Time Method R0 Resection Rate (Negative Margin Rate) At time of surgery The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
Morbidity and Mortality Rate Up to 30 days Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
Rate of Pathologic Complete Response of the Primary Tumor Up to 5 years The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.
Local Recurrence Rate Up to 5 years The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.
Trial Locations
- Locations (67)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Cancer Care Center at John Muir Health - Concord Campus
🇺🇸Concord, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
🇺🇸Walnut Creek, California, United States
St. Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
Praxair Cancer Center at Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Scroll for more (57 remaining)Mayo Clinic Scottsdale🇺🇸Scottsdale, Arizona, United States