Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003930
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
1999-11-01
Brief Title:
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-10
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 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 with chemotherapy and surgery may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery
PURPOSE Phase III trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder previously treated with transurethral tumor resection
Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy in achieving a complete response in this patient population
Assess the value of tumor parameters as prognostic factors for initial tumor response and recurrence-free survival in this patient population
OUTLINE Four to six weeks after prior transurethral resection patients receive induction therapy comprising paclitaxel IV over 1 hour on days 1 8 and 15 cisplatin IV over 1 hour on days 1 2 8 9 15 and 16 and radiotherapy twice daily on days 1-5 8-12 and 17
Four weeks after induction therapy patients undergo urologic evaluation At 1-2 weeks after evaluation patients with complete response receive consolidation therapy comprising paclitaxel IV over 1 hour on days 1 and 8 cisplatin IV over 1 hour on days 1 2 8 and 9 and radiotherapy twice daily on days 1-5 and 8-10 Patients with poor tumor response undergo a cystectomy
At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy patients receive adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV over 1 hour every 3 weeks Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 84 patients will be accrued for this study within 3 years
Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder previously treated with transurethral tumor resection
Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy in achieving a complete response in this patient population
Assess the value of tumor parameters as prognostic factors for initial tumor response and recurrence-free survival in this patient population
OUTLINE Four to six weeks after prior transurethral resection patients receive induction therapy comprising paclitaxel IV over 1 hour on days 1 8 and 15 cisplatin IV over 1 hour on days 1 2 8 9 15 and 16 and radiotherapy twice daily on days 1-5 8-12 and 17
Four weeks after induction therapy patients undergo urologic evaluation At 1-2 weeks after evaluation patients with complete response receive consolidation therapy comprising paclitaxel IV over 1 hour on days 1 and 8 cisplatin IV over 1 hour on days 1 2 8 and 9 and radiotherapy twice daily on days 1-5 and 8-10 Patients with poor tumor response undergo a cystectomy
At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy patients receive adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV over 1 hour every 3 weeks Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 84 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 |
|---|---|---|---|
| CDR0000067122 | None | None | None |