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Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

NCT ID: NCT01734798

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Bladder Cancer

Keywords

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locally advanced bladder cancer Postoperative radiotherapy Adjuvant chemotherapy Radical Cystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Radiation

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

Radiotherapy and Drug

Intervention Type OTHER

Arm 3

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

Group Type EXPERIMENTAL

gemcitabine and cisplatin

Intervention Type DRUG

Interventions

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Radiation

Intervention Type RADIATION

gemcitabine and cisplatin

Intervention Type DRUG

Radiotherapy and Drug

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed s. Zaghloul

Professor of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National cancer Institute-Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 29188298 (View on PubMed)

Other Identifiers

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Bladder-02

Identifier Type: -

Identifier Source: org_study_id