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

Bladder Cancer Clinical Trial

Official title:

Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01104350
• Other study ID #: 10-031
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 2010
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• external radiation therapy with gemcitabine
All patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement. Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy) Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy) Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy)

Locations

Country	Name	City	State
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	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the dose limiting toxicity and establish the maximal tolerated dose		2 years
Secondary	To determine the complete response rate of the primary tumor		4-6 weeks following consolidation therapy
Secondary	To determine the long term toxicity		2 years

External Links

•   Memorial Sloan Kettering Cancer Center