TerminatedNot Applicable

Daily Online Adaptive Short-Course Radiation Therapy and Concurrent Chemotherapy for Muscle-Invasive Bladder Cancer

Stopped: Low enrollment

United States2 participantsStarted 2023-02-02

Plain-language summary

This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle-invasive bladder cancer will translate into a decreased rate of acute (assessed weekly during chemo-radiotherapy) grade 3 or greater gastrointestinal/genitourinary toxicity compared with the historically reported rate for non-adaptive radiation therapy. The Common Terminology Criteria for Adverse Events (CTCAE) version 5 assessment tool will be utilized.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years.
✓. Patients must have histologically proven cT2-T4aN0M0 (AJCC v8) urothelial carcinoma of the bladder with an intact bladder. Mixed urothelial histology is permitted as long as there is some urothelial histology component and no small cell component present.
✓. Patients must have undergone an attempt at maximal transurethral resection of bladder tumor (TURBT) within 70 days prior to enrollment.
✓. A negative pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MRI scan, fine needle biopsy, extra peritoneal biopsy, or laparoscopic biopsy, per institutional standard of care.
✓. Patients must be planning to undergo concurrent pelvic radiation and chemotherapy with curative intent.
✓. ECOG performance status ≤2 (Karnofsky ≥60%).
✓. Ability to complete required patient questionnaires.
✓. Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

What they're measuring

Acute GI/GU Toxicity

Timeframe: Assessed during the 4 weeks of external beam radiation therapy

Trial details

NCT IDNCT05700227

SponsorVarian, a Siemens Healthineers Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-09

View on ClinicalTrials.gov More Muscle Invasive Bladder Urothelial Carcinoma trials