The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer

This study has been completed.
Sponsor:
Collaborators:
University of Turin, Italy
Universitätsklinikum Hamburg-Eppendorf
University of Eastern Piedmont
Information provided by (Responsible Party):
Marco Oderda, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT01697306
First received: September 21, 2012
Last updated: September 27, 2012
Last verified: September 2012
  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.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697306

Locations
Italy
A.O.U. San Giovanni Battista Molinette
Torino, TO, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
University of Turin, Italy
Universitätsklinikum Hamburg-Eppendorf
University of Eastern Piedmont
Investigators
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 August 27, 2014