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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lara Hathout, MD
- 電話番号：732-235-2465
- メール：Lh547@rutgers.edu
研究場所
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New Jersey
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New Brunswick、New Jersey、アメリカ、08901
- Rutgers Cancer Institut Jersey
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コンタクト：
- Lara Hathout
-
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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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研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient-Reported Quality of Life
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Lara M Hathout、Rutgers University - Cancer Institute
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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