Clinical trial · Interventional
BladdEr Full OR Empty for Pelvic Radiation Therapy
NCT06651697CI-TRIAL-00103460BEFORErecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvic Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Full bladder
- description
- Full bladder protocol for participants undergoing radiation therapy to pelvis for common malignancies.
- interventionNames
- Radiation: Radiation therapy
- type
- EXPERIMENTAL
- label
- Empty bladder
- description
- Empty bladder protocol for participants undergoing radiation therapy to pelvis for common malignancies.
- interventionNames
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 3 months post radiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.