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Recruiting Phase 3 NCT06651697

BladdEr Full OR Empty for Pelvic Radiation Therapy

Trial Parameters

Condition Pelvic Neoplasm
Sponsor University of California, San Diego
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-19
Completion 2028-04
Interventions
Radiation therapy

Brief Summary

The present study evaluates empty and full bladder protocols for radiation therapy of genitourinary (GU), gynecological (Gyn), and gastrointestinal (GI) malignancies of the pelvis.

Eligibility Criteria

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Persons, aged at least 18 years * Deemed eligible to undergo curative intent radiation therapy for primary GU, GI, or Gyn malignancy of the pelvis. * For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation * For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria: * Pregnancy * Tumor invading the bladder, as judged by the enrolling physician based on available clinical information * Contraindications to radiotherapy, including Crohn's disease and active connective tissue disorders such as scleroderma or uncontrolled lupus * Prior radiation therapy to an area requiring treatment in the present study

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