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

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy and Concurrent Gemcitabine Chemotherapy

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.

Group Type EXPERIMENTAL

external radiation therapy with gemcitabine

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No