Proton therapy for treating gynecologic cancer after surgery
Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
This study is testing a new type of radiation therapy after surgery to see if it helps women with cervical and endometrial cancer while causing fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Voorhees Township, New Jersey and 2 other locations) |
| Trial ID | NCT05758688 on ClinicalTrials.gov |
What this trial studies
This Phase II, single-arm study evaluates the use of Whole Pelvis Pencil Beam Scanning Proton Radiation (PBS PRT) as a post-surgical treatment for patients with gynecologic cancers, specifically cervical and endometrial cancer. The study aims to assess the rate of acute gastrointestinal toxicity associated with this radiation therapy in the adjuvant setting. Conducted at multiple Penn proton centers in the Philadelphia, Lancaster, and South New Jersey areas, patients will receive radiation doses of either 45 or 50.4 Gy in daily fractions. The goal is to improve treatment outcomes while minimizing side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed cervical or endometrial cancer who require adjuvant whole pelvic radiation therapy.
Not a fit: Patients with prior pelvic radiation, metastatic disease outside the pelvis, or active inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could reduce gastrointestinal toxicity while effectively managing gynecologic cancers post-surgery.
How similar studies have performed: Other studies using proton therapy for cancer treatment have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed cervical or endometrial cancer * Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy * Age of 18 years or older * Written informed consent * ECOG of 0-2 within 3 months of enrolling Exclusion Criteria: * Prior course of pelvic radiation * Metastatic disease outside of the pelvis * Active inflammatory bowel disease * Incapacity to provide informed consent
Where this trial is running
Voorhees Township, New Jersey and 2 other locations
- Virtua Health — Voorhees Township, New Jersey, United States (Recruiting)
- Lancaster General Health - Ann B. Barshinger Cancer Institute — Lancaster, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Neil K Taunk, MD, MSCTS — University of Pennsylvania
- Study coordinator: Project Manager
- Email: RadOncCRU@PennMedicine.upenn.edu
- Phone: 215-662-3790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.