Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114231
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2005-06-13
Brief Title:
Capecitabine Oxaliplatin and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 28 years
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 andor 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 28 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000433145 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA076001 |
| ACOSOG-Z6041 | None | None | None |
| U10CA180821 | NIH | None | None |
| U10CA076001 | NIH | None | None |