악성 복막 중피종 환자의 수술 후 추가 화학요법에 대한 연구
ICARuS II(세포감소 수술 후 복강내 화학요법): 악성 복막 중피종에 대한 세포감소 수술 및 온열 복강내 화학요법 후 정상온혈 복강내 화학요법 및 정맥내 화학요법에 대한 다기관, 무작위 제2상 시험
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Michael Offin, MD
- 전화번호: 646-608-3763
- 이메일: offinm@mskcc.org
연구 연락처 백업
- 이름: Garrett Nash, MD
- 전화번호: 212-639-8668
- 이메일: nashg@mskcc.org
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60637
- 모병
- University of Chicago (Data Collection Only)
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연락하다:
- Hedy Kindler, MD
- 전화번호: 773-702-1470
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- 아직 모집하지 않음
- University of Michigan (Data Collection Only)
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연락하다:
- Donnele Daley, MD
- 전화번호: 734-647-8902
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Missouri
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St Louis, Missouri, 미국, 63110
- 아직 모집하지 않음
- Washington University (Data Collection Only)
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연락하다:
- Trang Nguyen, MD
- 전화번호: 314-362-2280
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Nebraska
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Omaha, Nebraska, 미국, 68198-7680
- 아직 모집하지 않음
- University of Nebraska (Data collection only)
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연락하다:
- Jason Foster, MD
- 전화번호: 402-559-8941
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New Jersey
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Basking Ridge, New Jersey, 미국, 07920
- 모병
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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연락하다:
- Garrett Nash, MD, MPH
- 전화번호: 212-639-8668
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Middletown, New Jersey, 미국, 07748
- 모병
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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연락하다:
- Garrett Nash, MD
- 전화번호: 212-639-8668
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Montvale, New Jersey, 미국, 07645
- 모병
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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연락하다:
- Garrett Nash, MD
- 전화번호: 212-639-8668
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New Brunswick, New Jersey, 미국, 08903
- 아직 모집하지 않음
- Rutgers University (Data Collection Only)
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연락하다:
- H. Richard Alexander, MD
- 전화번호: 732-235-6780
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New York
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Commack, New York, 미국, 11725
- 모병
- Memorial Sloan Kettering Commack (Limited Protocol Activities)
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연락하다:
- Garrett Nash, MD
- 전화번호: 212-639-8668
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Harrison, New York, 미국, 10604
- 모병
- Memorial Sloan Kettering Westchester (Limited Protocol Activites)
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연락하다:
- Garrett Nash, MD
- 전화번호: 212-639-8668
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New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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연락하다:
- Garrett Nash, MD
- 전화번호: 212-639-8668
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Uniondale, New York, 미국, 11553
- 모병
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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연락하다:
- Garrett Nash, MD
- 전화번호: 212-639-8668
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15212
- 모병
- Allegheny Health Network (Data Collection Only)
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연락하다:
- Patrick Wagner, MD
- 전화번호: 833-246-7662
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression Free Survival
기간: up to 24 months
|
Progression Free Survival in the two treatment arms. |
up to 24 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Garrett Nash, MD, Memorial Sloan Kettering Cancer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- 23-145
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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