MRI-Guided Adaptive Radiotherapy for Limited Peritoneal Metastases (MARACAS Trial). (MARACAS)
MARACAS: A Phase II Trial of MRI-guided Adaptive Stereotactic RAdiotherapy in oligometastatiC Patients With Peritoneal Spread.
This prospective phase II study evaluates the efficacy and safety of MRI-guided stereotactic body radiotherapy (MRIgSBRT) in patients with oligometastatic peritoneal carcinomatosis from gastrointestinal or gynecological tumors. Eligible patients with up to 5 MRI-visible peritoneal lesions and PCI ≤20 will be treated with MRIgSBRT using a hybrid MRI-linear accelerator with online adaptive planning and real-time tumor tracking.
The primary endpoint is radiologic response rate according to RECIST 1.1 criteria. Secondary endpoints include overall survival, progression-free survival, local control, chemotherapy-free survival, and treatment-related toxicity. The study aims to assess MRIgSBRT as a safe and non-invasive treatment option for selected patients with limited peritoneal metastatic disease.
調査の概要
詳細な説明
Peritoneal carcinomatosis (PC) represents a frequent metastatic pattern in gastrointestinal and gynecological malignancies and is associated with poor prognosis and limited therapeutic options. Although cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) may improve outcomes in selected patients, many patients are not candidates for surgery because of recurrent disease, comorbidities, or poor performance status.
MRI-guided stereotactic body radiotherapy (MRIgSBRT) allows highly conformal radiation delivery with online adaptive planning and real-time tumor tracking, potentially improving treatment precision and sparing surrounding organs at risk in anatomically complex abdominal sites.
This prospective single-center phase II study will evaluate MRIgSBRT in patients with oligometastatic peritoneal carcinomatosis with up to 5 MRI-visible lesions and PCI ≤20. Treatment will be delivered using a hybrid MRI-linear accelerator with adaptive planning according to daily anatomical variations.
The primary endpoint is radiologic response rate according to RECIST 1.1 criteria. Secondary endpoints include overall survival, progression-free survival, local control, chemotherapy-free survival, and treatment-related toxicity assessed according to CTCAE v5.0.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Luca Boldrini
- 電話番号：+390630158195
- メール：luca.boldrini@policlinicogemelli.it
研究場所
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Roma、イタリア、000168
- Gemelli ART (Advanced Radiation Therapy)-Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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コンタクト：
- Luca Boldrini
- 電話番号：+390630155701
- メール：luca.boldrini@policlinicogemelli.it
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主任研究者：
- Luca Boldrini
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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:
- Age ≥18 years
- ECOG performance status 0-2
- Life expectancy ≥6 months
- Up to 5 MRI-visible peritoneal nodules
- PCI ≤20
- No prior radiotherapy in the same abdominal region within 6 months
- Signed informed consent
- History of prior CRS and/or HIPEC
Exclusion Criteria:
- Diffuse peritoneal carcinomatosis
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial)
- Significant comorbidities (such as: severe cardiac or coagulative disease, moderate or severe
- restrictive/obsiructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment.
- Pregnancy or breastfeeding
- MRI contraindications (e.g., pacemaker, severe claustrophobia)
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：MRI-guided SBRT
Patients with oligometastatic peritoneal carcinomatosis will receive MRI-guided stereotactic body radiotherapy (MRIgSBRT) delivered with a hybrid MRI-linear accelerator using online adaptive planning and real-time tumor tracking.
Treatment dose will range from 30 to 50 Gy in 5 fractions according to clinical judgment and organ-at-risk constraints.
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Patients will receive MRI-guided stereotactic body radiotherapy (MRIgSBRT) delivered using a hybrid MRI-linear accelerator with online adaptive planning and real-time tumor tracking.
Treatment will consist of 30-50 Gy delivered in 5 fractions according to clinical judgment, target characteristics, and organ-at-risk constraints.
Daily adaptive replanning may be performed to account for anatomical changes and optimize dose delivery in patients with oligometastatic peritoneal carcinomatosis.
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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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Radiological Response Rate (RR)
時間枠：Up to 12 months after completion of MRIgSBRT
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RR: The response rate will be calculated as the proportion of patients achieving a complete or partial radiological response out of the total number of evaluable patients according to RECIST 1.1 criteria
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Up to 12 months after completion of MRIgSBRT
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協力者と研究者
捜査官
- 主任研究者：Luca Boldrini、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
本研究に関する用語
その他の研究ID番号
- 26983
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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