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Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed s. Zaghloul, Cairo University
ClinicalTrials.gov Identifier:
NCT01734798
First received: November 19, 2012
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.


Condition Intervention Phase
Locally Advanced Bladder Cancer
 Radiation: Radiation
Drug: gemcitabine and cisplatin
Other: Radiotherapy and Drug
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy [ Time Frame: Five-year overall and disease-free survival. ] [ Designated as safety issue: Yes ]
    Regular follow up is performed every 2 months in the first 2 years postcystectomy and every 6 months thereafter. Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.


Secondary Outcome Measures:
  • comparison of the Local recurrence rate in the three Arms [ Time Frame: Five year local pelvic control rate ] [ Designated as safety issue: Yes ]
    Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.


Enrollment: 198
Study Start Date: December 2002
Study Completion Date: November 2012
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
post-operative radiotherapy will be done in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy Dose of Radiotherapy: 45 Gray Gy/30 fractions/3 weeks
 Radiation: Radiation
Experimental: Arm 2
adjuvant chemotherapy (gemcitabine and cisplatin) in addition to post operative radiotherapy in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
 Other: Radiotherapy and Drug
Experimental: Arm 3
Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
 Drug: gemcitabine and cisplatin

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients not more than 70 years old.
  • Radical cystectomy performed within 42 days with no microscopic or macroscopic residual after surgery (negative surgical safety margins)
  • Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN)
  • ECOG Performance Scale (0-2).
  • Adequate liver functions.
  • Adequate renal function serum (creatinine < 1.5 mg).
  • No evidence of distant metastasis or other malignancy.

Exclusion Criteria:

  • patients who received radiotherapy or chemotherapy prior to radical cystectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734798

Locations
Egypt
National cancer Institute-Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
  More Information

No publications provided

Responsible Party: Mohamed s. Zaghloul, Professor of Radiation Oncology, Cairo University
ClinicalTrials.gov Identifier: NCT01734798     History of Changes
Other Study ID Numbers: Bladder-02
Study First Received: November 19, 2012
Last Updated: November 22, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
locally advanced bladder cancer
Postoperative radiotherapy
Adjuvant chemotherapy
Radical Cystectomy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adjuvants, Immunologic
Gemcitabine
Cisplatin
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2013