Clinical trial · Interventional
Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer
RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
NCT05139368CI-TRIAL-00125923RT-PACEactive not recruitingN/AResults postedClinicalTrials.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)
This clinical trial studies the feasibility of using hypo-fractionated radiotherapy for the treatment of cervical or endometrial cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hypo-fractionated radiotherapy)
- description
- Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
Primary outcomes (2)
- measure
- Change in Toxicity - Bowel Summary Score
- timeFrame
- from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit
- description
- Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score. Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects aged \>= 18 years * Pathologically confirmed malignancy of the cervix or endometrium. Non-epithelial histologies are permitted. Adenocarcinoma in situ is also permitted * Patients must be status post hysterectomy for initial management of cervix or endometrial cancer * Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Recovery to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines * Life expectancy of \> 2 years * Chemotherapy can be administered at discretion of the treating radiation, medical, or gynecologic oncologist. Sequential therapy (radiation followed by chemotherapy) is preferred but not required Exclusion Criteria: * Prior abdominal or pelvic irradiation * Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks, unless chemotherapy is administered prior to RT. If chemotherapy is administered prior to RT, consult with PI regarding acceptable time frame. * Prior history of inflammatory bowel disease * The diagnosis of another malignancy within =\< 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, or bladder or of the cervix) * Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study
References
Publications (0)
Data not yet available
No reference posted for this study.