UPCC 27822 Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-surgical Gynecologic Cancers (PROPS GYN)
Enrolling By Invitation
18 years - 99 years
Female
Phase
2
25 participants needed
1 Location
Brief description of study
This research study is being done to study the safety and
toxicity of proton whole pelvis radiation, a type of external beam radiation
treatment, for gynecologic cancers after surgery.
Currently, for such gynecology cancers, Image- guided Intensity
Modulated Radiation Therapy (IG-IMRT) is being done after hysterectomy as the
standard treatment. IG-IMRT technique uses photon radiation which has known
side effects related to bowels and bladder. Whole pelvis proton radiation is delivered in the same way via an external beam, to the
same areas of the body (the whole pelvis) and in the same number of treatments
as IG- IMRT. However, protons have unique properties that help to decrease the
amount of radiation that goes to structures nearby the radiation target. Proton
radiation may decrease the amount of radiation exposure to the bowels, bladder
and pelvic bone. This may, in turn, decrease the amount of side effects that
patients experience from treatment.
This study will help to show how well proton radiation can
reduce the dose to nearby organs, and how much side effects do the patients
experience during and after the treatment.
Detailed description of study
The study will recruit 25 participants across 3
sites: PCAM, LGH, Virtua. The study duration for each of the participant is seven
and half months.
The study will include:
1.
Simulation visit: CT/MRI/PET
scan to measure the tumor. This is standard of care.
2. Treatment with proton
radiation: 5 or 6 weeks of proton whole pelvis radiation therapy. This is the
research trial treatment.
3.
Follow up: There
will be 3 follow up visits at 1 month, 3 month and 6 month after the last dose
of radiation treatment. This is standard of care.
There will be a
clinical exam done by the physician before starting treatment, 1 day during
each week of radiation treatment and at all the follow up visits. The
participant will also have to complete two questionnaires- EPIC urine and bowel
score and FACT- CX at following time points: simulation visit, 3rd and 5th week
of radiation treatment and all the follow up visits.
The surveys will be
completed in the Redcap data capture tool by the patients when they come for
their in-person visits.
EPIC urine and bowel
score is a questionnaire to assess patient reported toxicity to the radiation
treatment. FACT- CX is a questionnaire to capture quality of life of patients
during their cancer treatment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 18 years - 99 years
-
Gender: Female
·
Histologically
confirmed cervical or endometrial cancer
·
Indication for
adjuvant whole pelvic radiation therapy, with or without systemic therapy
·
Age of 18 years
or older
· Can
sign informed consent.
·
ECOG of 0-2
within 3 months of enrolling
Updated on
19 Feb 2026.
Study ID: 22-1706
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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