Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

Официальное название

RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer

Обзор

This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).

Вмешательства

• Лучевая терапия Hypofractionated Radiation
  Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less often. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
• Другое Clinical Follow-Up and Assessments
  At each visit, the subject will be evaluated for any signs of their endometrial cancer or symptoms returning (clinical disease recurrence) and any negative side effects associated with their prior radiation treatment. Study participants will also be asked to fill out a survey regarding bowel/urinary habits and quality of life questionnaires (known as the "EPIC questionnaire") during these visits. The data collected during these clinical follow up visits will be used to determine how effective hy

Первичные конечные точки

• The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1) [Срок оценки: 3-5 weeks]
• Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2) [Срок оценки: 3-5 weeks (end of treament)]

Вторичные конечные точки (5)

• Change in patient-reported acute urinary side effects [Срок оценки: 1 month post radiation]
• Change in gastrointestinal toxicity over time [Срок оценки: 1 month post radiation]
• Overall quality of life after treatment [Срок оценки: 2 years post treatment]
• Financial Distress of Treatment [Срок оценки: End of treatment]
• Treatment Satisfaction [Срок оценки: End of treatment]

Критерии участия

Критерии включения

• Diagnosis of primary cervical cancer or uterine cancer of any histology
• Age ≥ 18 years.
• Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO).
• Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
• Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
• Eastern Cooperative Oncology Group (ECOG) PS≤ 2
• Able to provide informed consent and willingness to sign an approved consent form

Критерии исключения

• Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
• Concurrent (or other) chemotherapy occurring at the time of study.
• Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment.
• History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis.
• Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
• Recommendation to undergo para-aortic nodal irradiation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Winship Cancer Institute, Emory University — Atlanta
• University of Illinois at Chicago (UIC) — Chicago
• University of Chicago — Chicago
• MD Anderson Cancer Center — Houston
• Huntsman Cancer Institute — Salt Lake City

Идентификаторы

NCT: NCT04683653 · IRB20-1390

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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