Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055601
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2003-03-06
Brief Title:
Combination Chemotherapy and Radiation Therapy WithWithout Surgery In Patients With Stage IIIII Bladder Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and GemcitabinePaclitaxelCisplatin Adjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-05
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 work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy RT uses high-energy x-rays to damage tumor cells It is not yet known which regimen of combination chemotherapy plus radiation therapy with or without surgery is more effective in treating bladder cancer
PURPOSE Randomized phase II trial to study the effectiveness of two combination chemotherapy regimens and radiation therapy with or without radical cystectomy in treating patients who have stage II or stage III bladder cancer
PURPOSE Randomized phase II trial to study the effectiveness of two combination chemotherapy regimens and radiation therapy with or without radical cystectomy in treating patients who have stage II or stage III bladder cancer
Detailed Description:
OBJECTIVES
Estimate the safety and tolerability of induction paclitaxel cisplatin and radiotherapy or fluorouracil cisplatin and radiotherapy followed by consolidation chemoradiotherapy or radical cystectomy and adjuvant gemcitabine paclitaxel and cisplatin in patients with operable stage II or III bladder cancer
Estimate the efficacy of these regimens in terms of complete response in patients who have undergone prior transurethral resection TUR
Estimate the efficacy of these regimens after TUR in terms of preserving the native tumor-free bladder 5 years after therapy in these patients
Estimate the function of the preserved bladder in patients treated with these regimens after TUR
Determine the value of tumor histopathologic molecular genetic and DNA content parameters as possible prognostic factors for initial tumor response and recurrence-free survival in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to T stage T2 vs T3T4 Patients are randomized to one of two treatment arms
Induction therapy weeks 1-3
Arm I Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and cisplatin IV over 1 hour on days 1-3 8-10 and 15-17 Patients also receive pelvic radiotherapy twice daily on days 1-5 8-12 and 15-17
Arm II Patients receive fluorouracil IV over 24 hours on days 1-3 and 15-17 and cisplatin IV over 1 hour on days 1-3 8-10 and 15-17 Patients also receive pelvic radiotherapy as in arm I
Patients in both arms who achieve complete response after induction therapy proceed to consolidation therapy on week 8 Patients with operable pT1 or worse tumor response proceed to radical cystectomy on week 9
Consolidation therapy weeks 8 and 9
Arm I Patients receive paclitaxel IV over 1 hour on days 1 and 8 and cisplatin IV over 1 hour on days 1 2 8 and 9 Patients also receive pelvic radiotherapy twice daily on days 1-5 and 8-10
Arm II Patients receive 5-FU IV over 24 hours on days 1-3 and 8-10 and cisplatin as in arm I Patients also receive radiotherapy as in arm I
Adjuvant chemotherapy weeks 21-33 or 17-29 Beginning 12 weeks after consolidation therapy or 8 weeks after radical cystectomy patients receive gemcitabine IV over 30-60 minutes paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 8 Treatment repeats every 3 weeks for 4 courses
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 96 patients 48 per treatment arm will be accrued for this study within 3 years
Estimate the safety and tolerability of induction paclitaxel cisplatin and radiotherapy or fluorouracil cisplatin and radiotherapy followed by consolidation chemoradiotherapy or radical cystectomy and adjuvant gemcitabine paclitaxel and cisplatin in patients with operable stage II or III bladder cancer
Estimate the efficacy of these regimens in terms of complete response in patients who have undergone prior transurethral resection TUR
Estimate the efficacy of these regimens after TUR in terms of preserving the native tumor-free bladder 5 years after therapy in these patients
Estimate the function of the preserved bladder in patients treated with these regimens after TUR
Determine the value of tumor histopathologic molecular genetic and DNA content parameters as possible prognostic factors for initial tumor response and recurrence-free survival in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to T stage T2 vs T3T4 Patients are randomized to one of two treatment arms
Induction therapy weeks 1-3
Arm I Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and cisplatin IV over 1 hour on days 1-3 8-10 and 15-17 Patients also receive pelvic radiotherapy twice daily on days 1-5 8-12 and 15-17
Arm II Patients receive fluorouracil IV over 24 hours on days 1-3 and 15-17 and cisplatin IV over 1 hour on days 1-3 8-10 and 15-17 Patients also receive pelvic radiotherapy as in arm I
Patients in both arms who achieve complete response after induction therapy proceed to consolidation therapy on week 8 Patients with operable pT1 or worse tumor response proceed to radical cystectomy on week 9
Consolidation therapy weeks 8 and 9
Arm I Patients receive paclitaxel IV over 1 hour on days 1 and 8 and cisplatin IV over 1 hour on days 1 2 8 and 9 Patients also receive pelvic radiotherapy twice daily on days 1-5 and 8-10
Arm II Patients receive 5-FU IV over 24 hours on days 1-3 and 8-10 and cisplatin as in arm I Patients also receive radiotherapy as in arm I
Adjuvant chemotherapy weeks 21-33 or 17-29 Beginning 12 weeks after consolidation therapy or 8 weeks after radical cystectomy patients receive gemcitabine IV over 30-60 minutes paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 8 Treatment repeats every 3 weeks for 4 courses
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 96 patients 48 per treatment arm 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 |
|---|---|---|---|
| NCI-2011-01578 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| CDR0000258303 | None | None | None |
| ECOG-R0233 | None | None | None |