Comparing full and empty bladder protocols for pelvic radiation therapy
BladdEr Full OR Empty for Pelvic Radiation Therapy
This study is testing whether having a full or empty bladder during pelvic radiation therapy helps deliver the right dose of radiation and reduces side effects for patients with certain cancers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06651697 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are eligible for curative intent radiation therapy for pelvic malignancies.
Not a fit: Patients with tumors invading the bladder or those with contraindications to radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved radiation therapy protocols that enhance treatment efficacy while reducing side effects for patients.
How similar studies have performed: Previous non-randomized studies have shown promising results for bladder empty protocols, suggesting potential benefits in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.