Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Locally Advanced Bladder Cancer

Treatments: Radiation: Radiation; Drug: gemcitabine and cisplatin; Other: Radiotherapy and Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT01734798

Bladder-02

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 3 patient groups

Arm 1

Experimental group

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

Treatment:

Radiation: Radiation

Arm 2

Experimental group

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

Treatment:

Other: Radiotherapy and Drug

Arm 3

Experimental group

Description:

Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy

Treatment:

Drug: gemcitabine and cisplatin