PROPS GYN: ADJUVANT PROTON WHOLE PELVIS RADIATION THERAPY

Recruiting

18-99 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: Between 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 01 Aug 2024. Study ID: 852760

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