RECRUITINGPhase 3INTERVENTIONAL
BladdEr Full OR Empty for Pelvic Radiation Therapy
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Provision of signed and dated willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
RADIATION
Radiation therapy
Radiation therapy with full bladder or empty bladder protocols
Locations (1)
University of California, San Diego
San Diego, California, United States