悪性腹膜中皮腫患者に対する術後の追加化学療法の研究
ICARuS II（細胞縮小手術後の腹腔内化学療法）：悪性腹膜中皮腫に対する細胞縮小手術および温熱腹腔内化学療法後の常温腹腔内化学療法および静脈内化学療法の多施設無作為化第II相試験
The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.
調査の概要
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：Michael Offin, MD
- 電話番号：646-608-3763
- メール：offinm@mskcc.org
研究連絡先のバックアップ
- 名前：Garrett Nash, MD
- 電話番号：212-639-8668
- メール：nashg@mskcc.org
研究場所
-
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Illinois
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Chicago、Illinois、アメリカ、60637
- 募集
- University of Chicago (Data Collection Only)
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コンタクト：
- Hedy Kindler, MD
- 電話番号：773-702-1470
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- まだ募集していません
- University of Michigan (Data Collection Only)
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コンタクト：
- Donnele Daley, MD
- 電話番号：734-647-8902
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Missouri
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St Louis、Missouri、アメリカ、63110
- まだ募集していません
- Washington University (Data Collection Only)
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コンタクト：
- Trang Nguyen, MD
- 電話番号：314-362-2280
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Nebraska
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Omaha、Nebraska、アメリカ、68198-7680
- まだ募集していません
- University of Nebraska (Data collection only)
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コンタクト：
- Jason Foster, MD
- 電話番号：402-559-8941
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New Jersey
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Basking Ridge、New Jersey、アメリカ、07920
- 募集
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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コンタクト：
- Garrett Nash, MD, MPH
- 電話番号：212-639-8668
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Middletown、New Jersey、アメリカ、07748
- 募集
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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コンタクト：
- Garrett Nash, MD
- 電話番号：212-639-8668
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Montvale、New Jersey、アメリカ、07645
- 募集
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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コンタクト：
- Garrett Nash, MD
- 電話番号：212-639-8668
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New Brunswick、New Jersey、アメリカ、08903
- まだ募集していません
- Rutgers University (Data Collection Only)
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コンタクト：
- H. Richard Alexander, MD
- 電話番号：732-235-6780
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New York
-
Commack、New York、アメリカ、11725
- 募集
- Memorial Sloan Kettering Commack (Limited Protocol Activities)
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コンタクト：
- Garrett Nash, MD
- 電話番号：212-639-8668
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Harrison、New York、アメリカ、10604
- 募集
- Memorial Sloan Kettering Westchester (Limited Protocol Activites)
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コンタクト：
- Garrett Nash, MD
- 電話番号：212-639-8668
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New York、New York、アメリカ、10065
- 募集
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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コンタクト：
- Garrett Nash, MD
- 電話番号：212-639-8668
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Uniondale、New York、アメリカ、11553
- 募集
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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コンタクト：
- Garrett Nash, MD
- 電話番号：212-639-8668
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15212
- 募集
- Allegheny Health Network (Data Collection Only)
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コンタクト：
- Patrick Wagner, MD
- 電話番号：833-246-7662
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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:
- Patient age 18 years or older, both sexes.
- Clinical diagnosis of MPM at enrolling institution.
- Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution.
- Complete or near-complete CRS achieved.
- Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
- ECOG performance status ≤ 1.
- Hematology: ANC ≥ 1,500/µl.
- Platelets > 75,000/µl.
- Adequate renal function: creatinine < 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml/min.
- Adequate hepatic function: bilirubin < 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL).
- Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study
- Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
Exclusion Criteria:
- Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy/immunotherapy for peritoneal mesothelioma.
- Subjects who have previously received platinum-containing chemotherapy regimens.
- Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
- Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.
- High suspicion for extra-abdominal metastases.
- Women who are pregnant or lactating.
- Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.
- Uncontrolled hypertension defined as >140/90 and not cleared for surgery at the time of consent.
- New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study.
- Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.
- Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
- Any condition that would preclude the ability to deliver appropriate IP therapy.
- Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.
- Life expectancy < 12 weeks.
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：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：IVC arm
Pemetrexed and cisplatin will be administered intravenously for a total of 4 to 6 cycles. Participants will receive 4 cycles, but can receive up to 6 cycles based on clinician discretion. Substitution with carboplatin allowed for pre-existing impairment of hearing, renal function, or neuropathy. |
Pemetrexed will be administered intravenously Cisplatin will be administered intravenously Possible substitution with carboplatin based on clinician discretion |
|
アクティブコンパレータ：NIPC arm
After completion of hyperthermic intraperitoneal chemotherapy/HIPEC, an intraperitoneal catheter with a subcutaneous reservoir will be inserted through the abdominal wall. When the participant's condition is considered stable by the physicians, the NIPC will be started. Pemetrexed and either cisplatin or carboplatin will be administered through the intraperitoneal port. |
Pemetrexed will be administered intravenously Cisplatin will be administered intravenously Possible substitution with carboplatin based on clinician discretion |
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 |
|---|---|---|
|
Progression Free Survival
時間枠：up to 24 months
|
Progression Free Survival in the two treatment arms. |
up to 24 months
|
協力者と研究者
捜査官
- 主任研究者：Garrett Nash, MD、Memorial Sloan Kettering Cancer
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 23-145
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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
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。