Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

Phase 1

Active, not recruiting

• Conditions: Bladder Cancer
• Interventions: Other: external radiation therapy with gemcitabine

• Registration Number: NCT01104350
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
• Karnofsky Performance Scale (KPS) ≥ 70%
• Age ≥18 years old
• Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
• Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin < 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
• Adequate renal function: calculated creatinine clearance > 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance
• Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.
• Patients must have the ability to understand and the willingness to sign a written informed consent document

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Exclusion Criteria

• Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
• Previous pelvic radiation therapy
• Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
• Prior cisplatin based neoadjuvant systemic chemotherapy for more than >4 cycles
• Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
• Women who are pregnant or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy and Concurrent Gemcitabine Chemotherapy	external radiation therapy with gemcitabine	This is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy.

Primary Outcome Measures

Name	Time	Method
To determine the dose limiting toxicity and establish the maximal tolerated dose	2 years

Secondary Outcome Measures

Name	Time	Method
To determine the complete response rate of the primary tumor	4-6 weeks following consolidation therapy
To determine the long term toxicity	2 years

Trial Locations

Locations (5)

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States