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Whole Pelvic Hypofractionated Radiotherapy for the Treatment of Non-Metastatic Cervical and Endometrial Cancer, RT-PACE Trial
Trial Status: active
This phase I/II trial finds out the best dose, possible benefits, and side effects of whole pelvic hypofractionated radiotherapy for the treatment of non-metastatic cervical and 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.
Inclusion Criteria
Diagnosis of primary cervical cancer or uterine cancer of any histology
Age >= 18 years
Non-metastatic (Federation of Gynecology and Obstetrics [FIGO] stage I-IIIC1 if uterine primary, FIGO Stage I-IVA if cervical primary)
Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required
Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable. Concurrent targeted therapy (i.e., trastuzumab, etc.) is permitted
Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) =< 2
Able to provide informed consent and willingness to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion Criteria
Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer
Concurrent cytotoxic chemotherapy
Gross residual disease post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists’ judgment
History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis
Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation
Recommendation to undergo para-aortic nodal irradiation
Additional locations may be listed on ClinicalTrials.gov for NCT04683653.
I. To determine the maximum tolerated dose-per-fraction (MTD) regimen of whole pelvic radiation therapy administered in the adjuvant setting for uterine or cervical cancer. (Phase I)
II. To establish the trial as feasible and to evaluate the change in patient-reported acute gastrointestinal toxicity after completion of hypofractionated radiation. (Phase II)
SECONDARY OBJECTIVES:
I. To estimate impact upon urinary toxicity over time.
II. To estimate impact upon gastrointestinal toxicity over time.
III. To assess quality of life following treatment.
IV. To quantify financial toxicity following treatment.
V. To assess satisfaction with decision-making following treatment.
EXPLORATORY OBJECTIVE:
I. To determine treatment efficacy by evaluating 2-year pelvic control and 2-year overall survival.
OUTLINE:
Patients undergo hypofractionated radiation therapy over 3-5 weeks.
After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years after completion of external beam radiation treatment on study or until death, whichever occurs first.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center