BladdEr Full OR Empty for Pelvic Radiation Therapy

NCT06651697 | Recruiting Phase 3 DMC

• 1 other identifier: 811100
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

malignancy of the pelvis; bladder; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  Acute any attribution GU and/or GI grade ≥2 toxicity. This will be defined as the percentage of patients with CTCAE version 5.0 GU and/or GI grade ≥2 toxicity within 3 months post radiation therapy. This will be defined as a co-primary endpoint.

  3 months post radiation

Study Arms (2)

Full bladder

ACTIVE COMPARATOR

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

Radiation: Radiation therapy

Empty bladder

EXPERIMENTAL

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

Radiation: Radiation therapy

Interventions

Radiation therapy RADIATION

Radiation therapy with full bladder or empty bladder protocols

Empty bladder; Full bladder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tyler Seibert, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler Seibert, MD, PhD

CONTACT

858 822 5354; CancerCTO@health.ucsd.edu

Rana McKay, MD

CONTACT

858 822 5354; CancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist, Associate Professor

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)