BladdEr Full OR Empty for Pelvic Radiation Therapy
ConditionPelvic Neoplasm
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Radiation therapy
RadiationRadiation therapy with full bladder or empty bladder protocols
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Full bladderActive comparator 1 intervention
Group B: Empty bladderExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
3 months post radiationSponsors and contacts
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Source ClinicalTrials.gov