Comparing full and empty bladder protocols for pelvic radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of using either a full or empty bladder during radiation therapy for patients with genitourinary, gynecological, and gastrointestinal malignancies of the pelvis. It aims to determine if bladder volume at the time of treatment affects the accuracy of radiation dose delivery and minimizes toxicity to surrounding tissues. Participants will undergo CT simulations to optimize radiation delivery, and their bladder status will be monitored throughout the treatment process. The study seeks to address the challenges associated with maintaining a full bladder during radiation therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Diego
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: Tyler Seibert, MD, PhD — University of California, San Diego
• Study coordinator: Tyler Seibert, MD, PhD
• Email: CancerCTO@health.ucsd.edu
• Phone: 858 822 5354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.