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Whole Pelvis Proton Radiation Therapy for the Treatment of Cervical or Endometrial Cancer after Surgery
Trial Status: active
This phase II trial tests how well whole pelvis (WP) proton radiation therapy works in treating patients with cervical or endometrial cancer after surgery. WP radiation with photon radiation is typically part of the treatment approach for patients with cervical or endometrial cancer. Although it may improve disease control, the side effects may have a negative effect on quality of life. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Proton beam radiation therapy uses streams of protons (tiny particles with a positive charge) that come from a special machine. This type of radiation kills tumor cells but does not damage nearby tissues. WP pencil beam scanning (PBS) proton radiation therapy (PRT) may decrease the amount of radiation exposure to the bowel, bladder and pelvic bones and reduce side effects in patients with cervical or endometrial cancers.
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
Eastern Cooperative Oncology Group (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
Additional locations may be listed on ClinicalTrials.gov for NCT05758688.
I. 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, with the Common Terminology Criteria for Adverse Events (CTCAE version [v] 5.0) criteria.
SECONDARY OBJECTIVES:
I. Estimate rate of acute clinician-reported genitourinary (GU) toxicity using WP PBS PRT.
II. To determine the rate of acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life using the Expanded Prostate Cancer Index Composite (EPIC) urinary and bowel score (expanded prostate cancer index composite) and Functional Assessment of Cancer Therapy- Cervical Cancer (FACT-Cx).
III. To determine loco-regional recurrence free survival, disease free survival, and overall survival.
OUTLINE:
Patients undergo WP PBS PRT once daily (QD) Monday-Friday for 5-6 weeks for a total of 25-28 treatments in the absence of disease progression or unacceptable toxicity. Patients also undergo pelvic examinations (exams) throughout study.
After completion of study treatment, patients are followed up at 1, 3 and 6 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
