Shorter radiation treatment for endometrial cancer

RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer

This study is testing a shorter and stronger radiation treatment for women with endometrial cancer to see if it works as well as the usual longer treatment.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Chicago (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 5 sites (Atlanta, Georgia and 4 other locations)
• Trial ID: NCT04683653 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and tolerability of a shorter course of pelvic radiation therapy, known as hypofractionation, for women with endometrial cancer. The approach involves administering a higher daily dose of radiation over a reduced number of treatment sessions while ensuring the total radiation dose remains effective. The study aims to determine the optimal dose and treatment schedule that can provide similar outcomes to standard radiation therapy. Participants will be closely monitored for safety and treatment response.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with non-metastatic endometrial cancer who have undergone definitive surgical treatment.

Not a fit: Patients with distant metastases or those who have not undergone definitive surgical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to a more efficient and less time-consuming treatment option for women with endometrial cancer.

How similar studies have performed: Other studies have explored hypofractionated radiation therapy with promising results, suggesting potential for success in this approach.

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.

Where this trial is running

Atlanta, Georgia and 4 other locations

• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (ACTIVE_NOT_RECRUITING)
• University of Illinois at Chicago (UIC) — Chicago, Illinois, United States (RECRUITING)
• University of Chicago — Chicago, Illinois, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Huntsman Cancer Institute — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Christina Son, MD — University of Chicago
• Study coordinator: Christina Son, MD

Conditions: Endometrial Cancer