Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00114231|
Recruitment Status : Completed
First Posted : June 14, 2005
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: capecitabine Drug: oxaliplatin Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Experimental: Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
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.
Other Name: Given IVDrug: oxaliplatin
Given IVProcedure: neoadjuvant therapy
Other Name: therapeutic conventional surgeryRadiation: radiation therapy
Other Name: irradiation, radiotherapy, therapy, radiation
- 3-Year Disease-free Survival [ Time Frame: 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.
- R0 Resection Rate (Negative Margin Rate) [ Time Frame: At time of surgery ]The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
- Morbidity and Mortality Rate [ Time Frame: Up to 30 days ]Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
- Rate of Pathologic Complete Response of the Primary Tumor [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114231
Show 67 Study Locations
|Study Chair:||Julio Garcia-Aguilar, MD, PhD||City of Hope Comprehensive Cancer Center|