Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006366
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-10-04
Brief Title:
Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2002-12
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 It is not yet known which regimen of radiation therapy plus chemotherapy is more effective for rectal cancer
PURPOSE Randomized phase II trial to compare two regimens of radiation therapy plus chemotherapy followed by surgery in treating patients who have locally advanced cancer of the rectum
PURPOSE Randomized phase II trial to compare two regimens of radiation therapy plus chemotherapy followed by surgery in treating patients who have locally advanced cancer of the rectum
Detailed Description:
OBJECTIVES
Compare the pathological complete response acute and late normal tissue morbidity patterns of failure and complete resection rates in patients with locally advanced adenocarcinoma of the distal rectum treated with neoadjuvant chemoradiotherapy comprised of hyperfractionated radiotherapy and fluorouracil vs conventional radiotherapy fluorouracil and irinotecan followed by radical resection
OUTLINE This is a randomized study Patients are stratified according to clinical stage T3 vs T4 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive hyperfractionated radiotherapy RT twice daily 5 days a week for 19 days Patients receive fluorouracil IV continuously over 7 days a week concurrently with RT Patients with clinical stage T3 or fixed T4 disease also receive a higher boost dose of RT to tumor
Arm II Patients receive conventional RT once daily 5 days a week for 25 days Patients receive fluorouracil IV continuously over 5 days a week concurrently with RT Patients receive irinotecan IV over 1 hour immediately prior to RT dose once weekly for 4 weeks Patients with clinical stage T3 or fixed T4 disease also receive a lower boost dose of RT to tumor
Within 4-10 weeks after completion of chemoradiotherapy patients on both arms undergo radical anterior resection or radical abdominal perineal resection with preferably a total mesorectal resection
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients 50 per arm will be accrued for this study within 18 months
Compare the pathological complete response acute and late normal tissue morbidity patterns of failure and complete resection rates in patients with locally advanced adenocarcinoma of the distal rectum treated with neoadjuvant chemoradiotherapy comprised of hyperfractionated radiotherapy and fluorouracil vs conventional radiotherapy fluorouracil and irinotecan followed by radical resection
OUTLINE This is a randomized study Patients are stratified according to clinical stage T3 vs T4 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive hyperfractionated radiotherapy RT twice daily 5 days a week for 19 days Patients receive fluorouracil IV continuously over 7 days a week concurrently with RT Patients with clinical stage T3 or fixed T4 disease also receive a higher boost dose of RT to tumor
Arm II Patients receive conventional RT once daily 5 days a week for 25 days Patients receive fluorouracil IV continuously over 5 days a week concurrently with RT Patients receive irinotecan IV over 1 hour immediately prior to RT dose once weekly for 4 weeks Patients with clinical stage T3 or fixed T4 disease also receive a lower boost dose of RT to tumor
Within 4-10 weeks after completion of chemoradiotherapy patients on both arms undergo radical anterior resection or radical abdominal perineal resection with preferably a total mesorectal resection
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients 50 per arm will be accrued for this study within 18 months
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 |
|---|---|---|---|
| CDR0000068239 | None | None | None |