Recruiting
Phase 3

Observational Study

Sponsor:

UCLA

Code:

NCT06651697

Conditions

Pelvic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation therapy

Study Details

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.

Conditions

Pelvic Neoplasm

Study ID

NCT06651697

Start date

Nov 19, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Full bladder

Full bladder protocol for participants undergoing radiation therapy to pelvis for common malignancies.

experimental: Empty bladder

Empty bladder protocol for participants undergoing radiation therapy to pelvis for common malignancies.

Interventions

Radiation therapy

Radiation therapy with full bladder or empty bladder protocols

Primary outcome measure

  • Acute toxicity [ Time Frame: 3 months post radiation ]

Central Contacts and Locations

Central contacts

Tyler Seibert, MD, PhD

858 822 5354CancerCTO@health.ucsd.edu

Rana McKay, MD

858 822 5354CancerCTO@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Tyler Seibert, MD, PhD

858-822-5354CancerCTO@health.ucsd.edu

Rana McKay, MD

858 822 5354CancerCTO@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • malignancy of the pelvis
  • bladder
  • radiation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-17.