The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer
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Purpose
To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: Gemcitabine 2 g Drug: BCG Vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial. |
- quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- comparison of the short term efficacy of the two treatments in terms of recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- comparison of the short term efficacy of the two treatments in terms of progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Gemcitabine-arm
7-15 days after TUR patients received six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline. Maintenance consisted in monthly instillations up to 1 year
|
Drug: Gemcitabine 2 g
six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline
Other Name: Gemzar, Eli Lilly SpA
|
|
Active Comparator: BCG-arm
7-15 days after TUR patients received an induction cycle of six weekly instillations of Connaught strain Bacillus Calmette-Guerin (BCG Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline. Maintenance consisted of 3 weekly instillations at 3, 6 and 12 months
|
Drug: BCG Vaccine
six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline
Other Name: BCG Connaught 1/3 dose
|
Detailed Description:
Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, >3 cm in diameter)
- WHO performance status ≤2
- age ≤85years
- BCG naive
- patients not treated with intravesical chemotherapy in the last 3 months.
Exclusion Criteria:
- presence of T1G3 or CIS
- preoperative urinary cytology positive for high-grade atypia
- inadequate bone marrow reserve (white blood cells <3 x 109/l, platelets <100 x 109/l)
- history of genito-urinary tuberculosis
- presence of uncontrolled urinary infections.
Contacts and Locations| Italy | |
| A.O.U. San Giovanni Battista Molinette | |
| Torino, TO, Italy, 10126 | |
| Principal Investigator: | Paolo Gontero, Professor | A.O.U. San Giovanni Battista Molinette |
More Information
Publications:
| Responsible Party: | Marco Oderda, MD, Azienda Ospedaliera San Giovanni Battista |
| ClinicalTrials.gov Identifier: | NCT01697306 History of Changes |
| Other Study ID Numbers: | CE 70/06 |
| Study First Received: | September 21, 2012 |
| Last Updated: | September 27, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Azienda Ospedaliera San Giovanni Battista:
|
non muscle invasive bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases BCG Vaccine Gemcitabine Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 17, 2013