Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer
調査の概要
詳細な説明
The aim of this prospective mono-institutional phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions in patients with locally unresectable pancreatic cancer.
Primary endpoint is to evaluate overall survival (OS); the overall survival time will be calculated from the start of chemotherapy to death. Secondary end points are to evaluate acute and late toxicities, freedom from local progression (FFLP) and progression free-survival (PFS). Acute and late toxicities will be scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Local progression will be defined according to RECIST criteria. Time to toxicity and time to local or distant progression will be defined from the start of chemotherapy.
Technical success will be defined as the ability to implant at least 2 fiducials in the tumor area. Migration will be defined as a change in inter-fiducial distance. Clinical success will be defined as the ability to guide the application of SBRT by using the fiducials. Any adverse event will be recorded (acute pancreatitis, clinically relevant upper GI bleeding requiring blood transfusion, abscesses in the area of the fiducials, sepsis).
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Milan
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Rozzano、Milan、イタリア、20089
- Humanitas Research Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board.
- Eighteen years of age or older,
- Minimum Karnofsky Performance Status of 70.
- Lesions cannot exceed 5 cm in maximum diameter.
- Absence of lymph-nodal metastases
- Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered.
- Baseline total body CT scan performed no more than 2 months before treatment.
- Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment).
- Acceptable organ and bone marrow function.
- Ability to maintain the set-up position during RT.
- All patients give informed consent and sign a study-specific informed consent form.
Exclusion Criteria:
- Metastatic disease
- Prior abdominal radiotherapy
- Other malignancies diagnosed within 5 years
- Gastric or duodenal obstruction.
- Concurrent chemotherapy.
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：SBRT and chemotherapy
Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery. Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor. The SBRT schedule will be [6 x 9 Gy = 54 Gy] delivered in consecutive days. |
Patients affected by locally unresectable pancreatic cancer receive integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and a Stereotactic Body Radiation Therapy with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions.
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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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Overall survival
時間枠：2 years
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Evaluation of SBRT after induction CT with FOLFIRINOX or Gemcitabine-Abraxane in terms of overall survival time that will be calculated from the start of chemotherapy to death.
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2 years
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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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Incidence of acute toxicities
時間枠：2 years
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Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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2 years
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Incidence of late toxicities
時間枠：4 years
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Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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4 years
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Freedom from local progression in treated patients
時間枠：2 years
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Evaluation of proportion of patients free from local progression according to RECIST criteria
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2 years
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Progression free-survival of treated patients
時間枠：2 years
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Evaluation of proportions of patients alive and free form progression according to RECIST criteria
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2 years
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協力者と研究者
捜査官
- 主任研究者：Marta Scorsetti, MD、Istituto Clinico Humanitas
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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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