Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146276
Status:
UNKNOWN
Last Update Posted:
2006-09-27
First Post:
2005-09-02
Brief Title:
Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer
Sponsor:
Association of Urologic Oncology AUO
Organization:
Association of Urologic Oncology AUO
Study Overview
Official Title:
Adjuvant vs Progression-Triggered Treatment With Gemcitabine After Radical Cystectomy for Locally Advanced Transitional Cell Carcinoma of the Bladder in Patients Not Suitable for Cisplatin-Based Chemotherapy - A Phase 3 Study
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
Primary Objective
To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma TCC of the bladder who are not suitable for cisplatin-based chemotherapy ie postoperative reduced renal function advanced age Patients are randomized to receive either adjuvant gemcitabine immediately after radical operation treatment arm A or no treatment control arm B Patients in the control arm are to be treated with gemcitabine as soon as tumor progression becomes evident clinically andor radiologically
Secondary Objectives
The secondary objectives of this study are
Estimation of time-specific survival probabilities irrespective of causes of death
Assessment of toxicity and tolerability of gemcitabine
Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy
Assessment of quality of life European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-C30
Study Design
This is an open-label prospective multicenter randomized controlled phase 3 two-arm study using gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting The patients will receive the following treatment
Arm A treatment gemcitabine 1250 mgm2 intravenously once a week for 2 weeks days 1 and 8 followed by 1-week rest period Repeat cycle on day 22 Maximum of 6 cycles Begin treatment until 3 months after radical operation within first 6 weeks is recommended
Arm B control No immediate post-surgery treatment Watchful waiting treatment only conditionally in case of progression with gemcitabine dose and schedule as in arm A
To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma TCC of the bladder who are not suitable for cisplatin-based chemotherapy ie postoperative reduced renal function advanced age Patients are randomized to receive either adjuvant gemcitabine immediately after radical operation treatment arm A or no treatment control arm B Patients in the control arm are to be treated with gemcitabine as soon as tumor progression becomes evident clinically andor radiologically
Secondary Objectives
The secondary objectives of this study are
Estimation of time-specific survival probabilities irrespective of causes of death
Assessment of toxicity and tolerability of gemcitabine
Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy
Assessment of quality of life European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-C30
Study Design
This is an open-label prospective multicenter randomized controlled phase 3 two-arm study using gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting The patients will receive the following treatment
Arm A treatment gemcitabine 1250 mgm2 intravenously once a week for 2 weeks days 1 and 8 followed by 1-week rest period Repeat cycle on day 22 Maximum of 6 cycles Begin treatment until 3 months after radical operation within first 6 weeks is recommended
Arm B control No immediate post-surgery treatment Watchful waiting treatment only conditionally in case of progression with gemcitabine dose and schedule as in arm A
Detailed Description:
Primary Objective
To analyse time to tumor progression in patients cystectomized for locally advanced TCC of the bladder who are not suitable for cisplatin-based chemotherapy ie postoperative reduced renal function advanced age Patients are randomized to receive either adjuvant Gemcitabine immediately after radical operation treatment arm A or no treatment control arm B Patients in the control arm are to be treated with Gemcitabine as soon as tumor progression becomes evident clinically andor radiologically
Secondary Objectives
The secondary objectives of this study are
Estimation of time-specific survival probabilities irrespective of causes of death
Assessment of toxicity and tolerability of Gemcitabine
Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy
Assessment of quality of life EORTC QLQ-C30
Study Design
This is an open-label prospective multicenter randomized controlled phase 3 two-arm study using Gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting The patients will receive the following treatment
Arm A treatment Gemcitabine 1250 mgm2 intravenously once a week for 2 weeks days 1 and 8 followed by 1-week rest period Repeat cycle on day 22 Maximum of 6 cycles Begin treatment until 3 months after radical operation within first 6 weeks is recommended
Arm B control No immediate post-surgery treatment Watchful waiting treatment only conditionally in case of progression with Gemcitabine dose and schedule as in arm A
To analyse time to tumor progression in patients cystectomized for locally advanced TCC of the bladder who are not suitable for cisplatin-based chemotherapy ie postoperative reduced renal function advanced age Patients are randomized to receive either adjuvant Gemcitabine immediately after radical operation treatment arm A or no treatment control arm B Patients in the control arm are to be treated with Gemcitabine as soon as tumor progression becomes evident clinically andor radiologically
Secondary Objectives
The secondary objectives of this study are
Estimation of time-specific survival probabilities irrespective of causes of death
Assessment of toxicity and tolerability of Gemcitabine
Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy
Assessment of quality of life EORTC QLQ-C30
Study Design
This is an open-label prospective multicenter randomized controlled phase 3 two-arm study using Gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting The patients will receive the following treatment
Arm A treatment Gemcitabine 1250 mgm2 intravenously once a week for 2 weeks days 1 and 8 followed by 1-week rest period Repeat cycle on day 22 Maximum of 6 cycles Begin treatment until 3 months after radical operation within first 6 weeks is recommended
Arm B control No immediate post-surgery treatment Watchful waiting treatment only conditionally in case of progression with Gemcitabine dose and schedule as in arm A
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 |
|---|---|---|---|
| AB 2200 | None | None | None |