Clinical trial NCT04683653: Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
Official title: RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Endometrial Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary cervical cancer or uterine cancer of any histology
* Age ≥ 18 years.
* Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO).
* Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
* Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
* Eastern Cooperative Oncology Group (ECOG) PS≤ 2
* Able to provide informed consent and willingness to sign an approved consent form

Exclusion Criteria:

* Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
* Concurrent (or other) chemotherapy occurring at the time of study.
* Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) 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.

Primary outcomes:
measure: The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)
timeFrame: 3-5 weeks
measure: Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2)
timeFrame: 3-5 weeks (end of treament)
Secondary outcomes:
measure: Change in patient-reported acute urinary side effects
timeFrame: 1 month post radiation
measure: Change in gastrointestinal toxicity over time
timeFrame: 1 month post radiation
measure: Overall quality of life after treatment
timeFrame: 2 years post treatment
measure: Financial Distress of Treatment
timeFrame: End of treatment
measure: Treatment Satisfaction
timeFrame: End of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago (UIC)
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Chicago
name: Christina Son, MD
role: PRINCIPAL_INVESTIGATOR
References: