Completed

NCT Number: NCT01734798

Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

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.

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Key information

Conditions

Locally Advanced Bladder Cancer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National cancer Institute-Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation

Gemcitabine and Cisplatin

Drug

Radiotherapy and Drug

Other

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Cairo University