Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
Recruitment status was Active, not recruiting
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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer|
- Disease-free survival as measured by clinical, radiological, or ultrasound exam at 3 years [ Designated as safety issue: No ]
- Rate of resectability as measured by the pathology report at surgery [ Designated as safety issue: No ]
- Procedure-specific morbidity and mortality rate as measured by NCI CTCAE one month after surgery [ Designated as safety issue: No ]
- Rate of pathologic complete response of the primary tumor as measured by RECIST at surgery [ Designated as safety issue: No ]
- Anorectal function and quality of life as measured by the fecal incontinence severity index, fecal incontinence quality of life questionnaire, and functional assessment of cancer therapy-colorectal questionnaire one year after surgery [ Designated as safety issue: No ]
- Feasibility of using molecular studies to assess surgical resection margins and tumor response as measured by ligation detection reaction-polymerase chain reaction after surgery [ Designated as safety issue: No ]
- Molecular markers associated with local tumor recurrence by several molecular techniques after completion of study treatment [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114231
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|Study Chair:||Julio Garcia-Aguilar, MD, PhD||Beckman Research Institute|