NCT06651697 BladdEr Full OR Empty for Pelvic Radiation Therapy
| NCT ID | NCT06651697 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, San Diego |
| Condition | Pelvic Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2024-11-19 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Tyler Seibert, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06651697 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pelvic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06651697 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06651697 currently recruiting?
Yes, NCT06651697 is actively recruiting participants. Contact the research team at CancerCTO@health.ucsd.edu for enrollment information.
Where is the NCT06651697 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06651697 clinical trial?
NCT06651697 is sponsored by University of California, San Diego. The principal investigator is Tyler Seibert, MD, PhD at University of California, San Diego. The trial plans to enroll 300 participants.