Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011960
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2001-03-03
Brief Title:
Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
Status:
COMPLETED
Status Verified Date:
2015-11
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 cisplatin and paclitaxel 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 Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery
PURPOSE Randomized phase II trial to study the effectiveness of cisplatin paclitaxel and radiation therapy with or without fluorouracil in treating patients who have stage IB stage IIB or stage IIIB stomach cancer that has been removed during surgery
PURPOSE Randomized phase II trial to study the effectiveness of cisplatin paclitaxel and radiation therapy with or without fluorouracil in treating patients who have stage IB stage IIB or stage IIIB stomach cancer that has been removed during surgery
Detailed Description:
OBJECTIVES
Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin paclitaxel and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 RTOG 90-18 Arm I closed to accrual as of 61803
Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study
Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor stage T1-2 vs T3 vs T4 and by number of involved lymph nodes none vs 1-3 vs 4 or more Patients are randomized to one of two treatment arms Arm I closed to accrual as of 61803
Arm I closed to accrual as of 61803 Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29
At 3-4 weeks after completion of chemotherapy patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5 8-12 15-19 22-26 and 29-33 Patients also receive paclitaxel IV over 3 hours on days 1 8 15 22 and 29
Arm II Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29
At 3-4 weeks after completion of chemotherapy patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5 8-12 15-19 22-26 and 29-33 Patients also receive cisplatin IV over 1 hour on days 1 8 15 22 and 29
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 94 patients will be accrued for this study within 3 years
Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin paclitaxel and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 RTOG 90-18 Arm I closed to accrual as of 61803
Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study
Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor stage T1-2 vs T3 vs T4 and by number of involved lymph nodes none vs 1-3 vs 4 or more Patients are randomized to one of two treatment arms Arm I closed to accrual as of 61803
Arm I closed to accrual as of 61803 Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29
At 3-4 weeks after completion of chemotherapy patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5 8-12 15-19 22-26 and 29-33 Patients also receive paclitaxel IV over 3 hours on days 1 8 15 22 and 29
Arm II Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29
At 3-4 weeks after completion of chemotherapy patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5 8-12 15-19 22-26 and 29-33 Patients also receive cisplatin IV over 1 hour on days 1 8 15 22 and 29
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 94 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000068464 | None | None | None |