Back to resultsAdjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Primary Purpose
Locally Advanced Bladder Cancer
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Radiation
gemcitabine and cisplatin
Radiotherapy and Drug
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Bladder Cancer focused on measuring locally advanced bladder cancer, Postoperative radiotherapy, Adjuvant chemotherapy, Radical Cystectomy
Eligibility 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
Sites / Locations
- National cancer Institute-Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
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
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
Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
Outcomes
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01734798
Brief Title
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Official Title
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Bladder Cancer
Keywords
locally advanced bladder cancer, Postoperative radiotherapy, Adjuvant chemotherapy, Radical Cystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Type
Drug
Intervention Name(s)
gemcitabine and cisplatin
Intervention Type
Other
Intervention Name(s)
Radiotherapy and Drug
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Five-year overall and disease-free survival.
Secondary Outcome Measure Information:
Title
comparison of the Local recurrence rate in the three Arms
Description
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.
Time Frame
Five year local pelvic control rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National cancer Institute-Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
29188298
Citation
Zaghloul MS, Christodouleas JP, Smith A, Abdallah A, William H, Khaled HM, Hwang WT, Baumann BC. Adjuvant Sandwich Chemotherapy Plus Radiotherapy vs Adjuvant Chemotherapy Alone for Locally Advanced Bladder Cancer After Radical Cystectomy: A Randomized Phase 2 Trial. JAMA Surg. 2018 Jan 17;153(1):e174591. doi: 10.1001/jamasurg.2017.4591. Epub 2018 Jan 17.
Results Reference
derived
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Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
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