Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023751
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-09-13
Brief Title:
Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With 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 Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers
Status:
COMPLETED
Status Verified Date:
2016-07
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 use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer
PURPOSE Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer
PURPOSE Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer
Detailed Description:
OBJECTIVES
Determine the overall disease-free and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy
Determine the local regional and distant recurrence rates in patients treated with these regimens
Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens
Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens
Determine the anorectal urinary and sexual function effects in patients treated with these regimens
Determine the non-functional treatment morbidity and mortality exclusive of anorectal urinary and sexual function effects in patients treated with these regimens
Determine the overall survival of patients with pathology exclusions undergoing local excision
Determine the efficacy of the current standard in detecting recurrence during follow-up including office visits blood tests and proctoscopy in patients treated with these regimens
OUTLINE This is a multicenter study
All patients undergo full thickness disc excision Patients with T3 disease or positive surgical margins after surgery are removed from study Patients with T1 disease and negative surgical margins after surgery are observed Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy
Beginning 42 days after surgery T2 patients receive leucovorin calcium CF IV over 2 hours with fluorouracil 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks Beginning 2 weeks after the completion of chemotherapy patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy Beginning 2 weeks after the completion of chemoradiotherapy patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks Chemotherapy repeats after 2 weeks rest for a total of 2 courses
Patients are followed every 3 months for 2 years and then every 6 months for 5 years
Determine the overall disease-free and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy
Determine the local regional and distant recurrence rates in patients treated with these regimens
Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens
Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens
Determine the anorectal urinary and sexual function effects in patients treated with these regimens
Determine the non-functional treatment morbidity and mortality exclusive of anorectal urinary and sexual function effects in patients treated with these regimens
Determine the overall survival of patients with pathology exclusions undergoing local excision
Determine the efficacy of the current standard in detecting recurrence during follow-up including office visits blood tests and proctoscopy in patients treated with these regimens
OUTLINE This is a multicenter study
All patients undergo full thickness disc excision Patients with T3 disease or positive surgical margins after surgery are removed from study Patients with T1 disease and negative surgical margins after surgery are observed Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy
Beginning 42 days after surgery T2 patients receive leucovorin calcium CF IV over 2 hours with fluorouracil 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks Beginning 2 weeks after the completion of chemotherapy patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy Beginning 2 weeks after the completion of chemoradiotherapy patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks Chemotherapy repeats after 2 weeks rest for a total of 2 courses
Patients are followed every 3 months for 2 years and then every 6 months for 5 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-80002 | None | None | None |
| SWOG-C80002 | None | None | None |
| CDR0000068858 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |