Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

NCT01734798 | Completed Phase 3 DMC

• 1 other identifier: Bladder-02
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Bladder Cancer

Keywords

locally advanced bladder cancer; Postoperative radiotherapy; Adjuvant chemotherapy; Radical Cystectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Five-year overall and disease-free survival.

Secondary Outcomes (1)

• comparison of the Local recurrence rate in the three Arms

  Five year local pelvic control rate

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Radiation: Radiation

Arm 2

EXPERIMENTAL

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

Other: Radiotherapy and Drug

Arm 3

EXPERIMENTAL

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

Drug: gemcitabine and cisplatin

Interventions

Radiation RADIATION

Arm 1

gemcitabine and cisplatin DRUG

Arm 3

Radiotherapy and Drug OTHER

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients who received radiotherapy or chemotherapy prior to radical cystectomy

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National cancer Institute-Cairo University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29188298 DERIVED

MeSH Terms

Interventions

Radiation; Gemcitabine; Cisplatin; Radiotherapy; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Physical Phenomena; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 28, 2012
• Study Start: December 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: November 1, 2012
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

EG (1)