Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer (ADAPT-EC)
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study
연구 개요
상태
정황
상세 설명
The purpose of this research study is to evaluate a new way of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment. If you take part in the research, you will receive radiation therapy using MR-guided imaging. This involves daily radiation treatments that may be adjusted based on imaging taken at each session (called adaptive radiotherapy). This approach is considered investigational because it is not yet a standard treatment for endometrial cancer. Your time in the research will take Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments due to the imaging and treatment planning performed on the same day.The purpose of this research study is to evaluate a new method of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of the treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment.
If you participate in this research, you will receive radiation therapy guided by MR imaging. This will involve daily radiation treatments that may be adjusted based on imaging taken at each session (known as adaptive radiotherapy). This approach is considered investigational as it is not yet a standard treatment for endometrial cancer.
Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments because imaging and treatment planning are performed on the same day.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Lara Hathout, MD
- 전화번호: 732-235-2465
- 이메일: Lh547@rutgers.edu
연구 장소
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New Jersey
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New Brunswick, New Jersey, 미국, 08901
- Rutgers Cancer Institut Jersey
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연락하다:
- Lara Hathout
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Histologically confirmed endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma, or dedifferentiated histology).
- Indication for adjuvant pelvic radiotherapy (± vaginal brachytherapy) for HIR defined by the ASTRO guidelines and GOG-99(7, 9) :
- Age
- High-grade histology (grade 2-3)
- Depth of myometrial invasion
- LVSI
- Positive pelvic nodes
- Cervical stromal invasion
- Presence of poor prognostic molecular markers
- Age ≥18 years.
- Ability to provide informed consent.
- Eligible to receive adjuvant systemic therapy, if indicated, with a minimum 3-week interval between chemotherapy and radiotherapy.
- Willing and able to complete EORTC QLQ-C30 and EN-24 questionnaires in a validated language version.
Exclusion Criteria:
- Prior pelvic radiotherapy.
- Contraindication to pelvic radiotherapy (e.g., active connective tissue disorder or inflammatory bowel disease).
Presence of a hip prosthesis that would compromise treatment planning or delivery.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental: MR-guided Adaptive Pelvic IMRT
Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk.
Vaginal brachytherapy may be administered following IMRT at the treating physician's discretion per institutional standards.
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Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI guidance and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity
기간: Within 90 days after completion of treatment
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Defined as the number and proportion of participants experiencing grade ≥2 acute gastrointestinal or genitourinary treatment-related adverse events occurring within 90 days after completion of MR-guided adaptive pelvic IMRT, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, a standardized grading system for adverse events ranging from Grade 1 (mild) to Grade 5 (death related to adverse event)
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Within 90 days after completion of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient-Reported Quality of Life
기간: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Assessed using the EORTC QLQ-C30 to evaluate quality of life and symptom burden over time.
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Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Patient Reported Quality of Life
기간: Time Frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Description: Assessed using the EN-24 questionnaire to evaluate quality of life and symptom burden over time.
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Time Frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Disease-Free Survival
기간: Up to 2 years after completion of treatment.
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Disease-free survival will be measured as the time from completion of MR-guided adaptive pelvic IMRT to the first documented recurrence or death from any cause, whichever occurs first.
Recurrence will be assessed by clinical evaluation and/or imaging according to institutional standards.
Participants without recurrence or death will be censored at the date of last disease assessment.
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Up to 2 years after completion of treatment.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lara M Hathout, Rutgers University - Cancer Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 152601
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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