Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002490
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Radiation Therapy Chemotherapy or Observation in Treating Patients With Bladder Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
Status:
COMPLETED
Status Verified Date:
2001-06
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 chemotherapy with radiation therapy may kill more tumor cells It is not known whether receiving either radiation therapy chemotherapy or observation is more effective for cancer of the bladder
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy chemotherapy or observation following tumor surgery in treating patients who have bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy chemotherapy or observation following tumor surgery in treating patients who have bladder cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I grade 3 transitional cell carcinoma of the bladder
Determine the toxicity of radical radiotherapy in these patients
Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center extent of tumor single tumor without carcinoma in situ CIS vs multiple tumors or CIS and WHO performance status Patients with a single tumor and no CIS are randomized to arm I or II Patients with multiple tumors or CIS are randomized to arm II or III
Arm I Patients undergo observation only
Arm II Patients undergo radical radiotherapy 5 days a week for 6 weeks Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study
Arm III Patients receive intravesical BCG or mitomycin at the discretion of the physician weekly for 6-12 weeks
Patients on arms I and III are followed at 3 months after randomization All patients are followed at 6 9 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I grade 3 transitional cell carcinoma of the bladder
Determine the toxicity of radical radiotherapy in these patients
Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center extent of tumor single tumor without carcinoma in situ CIS vs multiple tumors or CIS and WHO performance status Patients with a single tumor and no CIS are randomized to arm I or II Patients with multiple tumors or CIS are randomized to arm II or III
Arm I Patients undergo observation only
Arm II Patients undergo radical radiotherapy 5 days a week for 6 weeks Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study
Arm III Patients receive intravesical BCG or mitomycin at the discretion of the physician weekly for 6-12 weeks
Patients on arms I and III are followed at 3 months after randomization All patients are followed at 6 9 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN65282717 | None | None | None |
| MRC-BS06 | None | None | None |
| EU-91019 | None | None | None |