Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

November 22, 2012 updated by: Mohamed s. Zaghloul, Cairo University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • National Cancer Institute-Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Five-year overall and disease-free survival.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of the Local recurrence rate in the three Arms
Time Frame: Five year local pelvic control rate
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.
Five year local pelvic control rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 22, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 22, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bladder-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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