- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01734798
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
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Cairo, Egypt
- National Cancer Institute-Cairo University
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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
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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
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Experimental: Arm 3
Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
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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.
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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.
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Five-year overall and disease-free survival.
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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
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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.
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Five year local pelvic control rate
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
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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