Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021398
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2001-07-11
Brief Title:
Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Study Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2020-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery
PURPOSE Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer
PURPOSE Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer
Detailed Description:
OBJECTIVES I Determine the local recurrence rate disease-free survival and overall survival of patients with stage II or III rectal cancer treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection and adjuvant fluorouracil and leucovorin calcium II Determine the toxicity rate in patients treated with this regimen III Correlate failure-free survival with ultrasound-determined preoperative staging in patients treated with this regimen IV Determine the quality of life of patients treated with this regimen V Determine if toxicity due to treatment daily stool frequency sexual dysfunction and disease-free survival correlates with quality of life parameters in patients treated with this regimen VI Correlate clinical selection criteria with ability to perform sphincter-sparing surgery in patients treated with this regimen VII Determine post-chemoradiotherapy pathological response margin status and lymph node status and correlate these factors with initial clinico-pathologic findings in patients treated with this regimen
OUTLINE Patients undergo pelvic radiotherapy once daily five days a week for 5 weeks followed by boost radiotherapy twice daily for 7 days Patients also receive neoadjuvant fluorouracil IV continuously over days 1-4 and 36-40 Patients undergo surgical resection 4-6 weeks after completion of radiotherapy At 4 weeks after surgery patients receive adjuvant leucovorin calcium IV and fluorouracil IV once daily five days a week Treatment continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the completion of pelvic and boost radiotherapy at 4 weeks after completion of chemoradiotherapy prior to surgery and then at 3 6 and 12 months after completion of study therapy Patients are followed every 3 months for 2 years every 4 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 23-41 patients will be accrued for this study
OUTLINE Patients undergo pelvic radiotherapy once daily five days a week for 5 weeks followed by boost radiotherapy twice daily for 7 days Patients also receive neoadjuvant fluorouracil IV continuously over days 1-4 and 36-40 Patients undergo surgical resection 4-6 weeks after completion of radiotherapy At 4 weeks after surgery patients receive adjuvant leucovorin calcium IV and fluorouracil IV once daily five days a week Treatment continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the completion of pelvic and boost radiotherapy at 4 weeks after completion of chemoradiotherapy prior to surgery and then at 3 6 and 12 months after completion of study therapy Patients are followed every 3 months for 2 years every 4 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 23-41 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA006927 | NIH | None | None |
| FCCC-96071 | None | None | None |
| NCI-G01-1988 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |