Proton Radiation for Uterine Cancer

(PROPS GYN Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Neil K Taunk, MD, MSCTS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Prior pelvic radiation, Metastatic disease, Inflammatory bowel disease, others

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Whole Pelvis Pencil Beam Scanning Proton Radiation (PBS PRT) for uterine cancer?

Research shows that Pencil Beam Scanning Proton Therapy (PBS) can reduce radiation exposure to healthy tissues compared to other radiation methods, as seen in treatments for rectal and breast cancer. This suggests that PBS might also be effective in minimizing side effects for uterine cancer patients.

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Is proton radiation therapy safe for humans?

Proton radiation therapy, including pencil beam scanning (PBS), has been studied for various cancers and is generally considered safe. Studies have shown it can reduce radiation exposure to normal tissues and lower the risk of secondary cancers compared to other radiation therapies.

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How is Whole Pelvis Pencil Beam Scanning Proton Radiation (PBS PRT) different from other treatments for uterine cancer?

Whole Pelvis Pencil Beam Scanning Proton Radiation (PBS PRT) is unique because it uses a precise form of proton therapy that targets the cancer more accurately, potentially reducing damage to surrounding healthy tissues compared to traditional radiation methods. This precision may lead to fewer side effects and better protection of nearby organs.

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Eligibility Criteria

This trial is for adults over 18 with confirmed cervical or endometrial cancer who need additional radiation therapy after surgery. Participants should be able to perform daily activities with minimal assistance (ECOG 0-2) and must provide written consent.

Inclusion Criteria

My cancer is confirmed to be either cervical or endometrial.

I am recommended to have radiation therapy for my pelvic area, with or without additional treatments.

You have given permission in writing to take part in the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive Whole Pelvis Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions.

5-6 weeks

Follow-up

Participants are monitored for acute clinician-reported gastrointestinal (GI) and genitourinary (GU) toxicity, quality of life, and survival outcomes.

Up to 6 months

Long-term follow-up

Participants are monitored for loco-regional recurrence free survival, disease free survival, and overall survival.

Up to 2 years

Participant Groups

The study is testing a type of targeted radiation called Whole Pelvis Pencil Beam Scanning Proton Radiation in patients who have had surgery for gynecologic cancers, aiming to reduce gastrointestinal side effects.

Group I: Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) Experimental Treatment 1 Intervention

The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.

Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Proton Therapy for:

• Gynecologic cancers including cervical, ovarian, uterine, vaginal, and vulvar cancers

🇪🇺 Approved in European Union as Proton Therapy for:

• Gynecologic cancers including cervical, ovarian, uterine, vaginal, and vulvar cancers

🇨🇦 Approved in Canada as Proton Therapy for:

• Gynecologic cancers including cervical, ovarian, uterine, vaginal, and vulvar cancers

🇯🇵 Approved in Japan as Proton Therapy for:

• Gynecologic cancers including cervical, ovarian, uterine, vaginal, and vulvar cancers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Lancaster General Health - Ann B. Barshinger Cancer Institute Lancaster, PA

University of Pennsylvania Philadelphia, PA

Virtua Health Voorhees, NJ

Penn Medicine Philadelphia, PA

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania Lead Sponsor

University of Pennsylvania Lead Sponsor

Abramson Cancer Center at Penn Medicine Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Initial Report of Pencil Beam Scanning Proton Therapy for Posthysterectomy Patients With Gynecologic Cancer. [2020] To report the acute toxicities associated with pencil beam scanning proton beam radiation therapy (PBS) for whole pelvis radiation therapy in women with gynecologic cancers and the results of a dosimetric comparison of PBS versus intensity modulated radiation therapy (IMRT) plans.

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Preoperative Short-Course Pencil Beam Scanning Proton Therapy for Patients With Rectal Cancer. [2022] For treatment of rectal cancer, pencil beam scanning proton therapy (PBS-PT) may reduce radiation exposure to normal tissues compared with 3-dimensional conformal photon radiation therapy (3DCRT) or volumetric modulated arc photon radiation therapy (VMAT). The purpose of this study was to report the clinical implementation and dosimetric analysis of preoperative short-course PBS-PT for rectal cancer.

3. England pubmed.ncbi.nlm.nih.gov

Proton pencil beam scanning reduces secondary cancer risk in breast cancer patients with internal mammary chain involvement compared to photon radiotherapy. [2021] Proton pencil beam scanning (PBS) represents an interesting option for the treatment of breast cancer (BC) patients with nodal involvement. Here we compare tangential 3D-CRT and VMAT to PBS proton therapy (PT) in terms of secondary cancer risk (SCR) for the lungs and for contralateral breast.

4. Ireland pubmed.ncbi.nlm.nih.gov

Patient reported outcomes following proton pencil beam scanning vs. passive scatter/uniform scanning for localized prostate cancer: Secondary analysis of PCG 001-09. [2022] Although pencil beam scanning (PBS) is the most conformal method for proton beam therapy (PBT) delivery, it is unknown if outcomes differ compared to treatment with passive scatter/uniform scanning (PS/US). This analysis compares patient reported outcomes (PRO) changes following PBS and PS/US for prostate cancer (PC) in a prospective multicenter registry study.

5. Ireland pubmed.ncbi.nlm.nih.gov

Current delivery limitations of proton PBS for FLASH. [2021] Proton Pencil Beam Scanning (PBS) is an attractive solution to realize the advantageous normal tissue sparing elucidated from FLASH high dose rates. The mechanics of PBS spot delivery will impose limitations on the effective field dose rate for PBS.

6. England pubmed.ncbi.nlm.nih.gov

Pencil Beam Scanning Proton Therapy for Paediatric Neuroblastoma with Motion Mitigation Strategy for Moving Target Volumes. [2022] More efforts are required to minimise late radiation side-effects for paediatric patients. Pencil beam scanning proton beam therapy (PBS-PT) allows increased sparing of normal tissues while maintaining conformality, but is prone to dose degradation from interplay effects due to respiratory motion. We report our clinical experience of motion mitigation with volumetric rescanning (vRSC) and outcomes of children with neuroblastoma.

7. United States pubmed.ncbi.nlm.nih.gov

Implementation of novel measurement-based patient-specific QA for pencil beam scanning proton FLASH radiotherapy. [2023] Several studies have shown pencil beam scanning (PBS) proton therapy is a feasible and safe modality to deliver conformal and ultra-high dose rate (UHDR) FLASH radiation therapy. However, it would be challenging and burdensome to conduct the quality assurance (QA) of the dose rate along with conventional patient-specific QA (psQA).

8. Ireland pubmed.ncbi.nlm.nih.gov

Inter-fraction motion robustness and organ sparing potential of proton therapy for cervical cancer. [2021] Large-field photon radiotherapy is current standard in the treatment of cervical cancer patients. However, with the increasing availability of Pencil Beam Scanning Proton Therapy (PBS-PT) and robust treatment planning techniques, protons may have significant advantages for cervical cancer patients in the reduction of toxicity. In this study, PBS-PT and photon Volumetric Modulated Arc Therapy (VMAT) were compared, examining target coverage and organ at risk (OAR) dose, taking inter- and intra-fraction motion into account.