- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03150628
Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study (CISCA)
Rationale: For patients with peritoneal metastases of gastric origin, there is no consensus on the optimal treatment strategy. Several Asian and Western studies demonstrated hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CS) to result in a prolonged survival compared to palliative systemic treatment. Morbidity and mortality rates of HIPEC and CS appear to be acceptable. In the Netherlands, this treatment is not yet introduced, therefore patients with peritoneal metastases of gastric origin are precluded from surgery and will be treated with palliative chemotherapy or best support of care.
Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with peritoneal metastases of gastric cancer, in terms of morbidity and mortality. Secondary objective is to determine the effect on survival and recurrence.
Study design: Mono centre prospective phase II single-arm feasibility study.
Study population: Western patients diagnosed with resectable (cT1-4b, N1-3) gastric cancer with clinical or pathologically proven peritoneal metastases without distant metastases.
Intervention: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Cytoreductive Surgery (CS) with Cisplatin.
Main study parameters/endpoints: Primary outcome is the safety and feasibility of the intervention, measured by the percentage of overall surgical complications grade ≥3 as stated by the Common Terminology Criteria for Adverse Events. Secondary outcomes are intraoperative events, postoperative morbidity and mortality, postoperative recovery, including quality of life, and disease free- and overall survival.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The additional burden for the patient mainly consists of HIPEC and CS.Furthermore, patients will undergo additional staging in order to exclude unresectable disease, and neoadjuvant chemotherapy regimen (3 drugs) instead of a palliative chemotherapy regimen (2 drugs). Postoperative care and outpatient visits are performed according to current protocols on HIPEC and CS for colon cancer and nation-wide protocols on gastric cancer surgery. The study is associated with a high risk classification. As there is a potential survival benefit, a small chance for curation and possibly a higher quality of life, we consider the additional burden and risks justified. This study is designed as a one group study, which eliminates group relatedness.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Utrecht, 네덜란드, 3584 CX
- University Medical Center Utrecht
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically proven adenocarcinoma of the stomach.
- Surgical resectable carcinoma (T1-4b, N1-3) (table 1)
- Pathological proven peritoneal metastases
- Peritoneal Cancer Index (PCI) ≤12
- WHO performance status 0,1 or 2 and ASA 1-3
- Age ≥ 18
- Written informed consent
Exclusion Criteria:
- Distant metastases other than peritoneal metastases
- Siewert type I/II gastro-esophageal junction tumor 22.
- Peritoneal carcinomatosis as a presentation of recurrent disease
- Pregnancy
Any contraindication to cisplatin, e.g.
- Hypersensitivity
- HIV infection
- inadequate bone marrow function (ANC <1.5x109/L or Platelets <100x109/L)
- inadequate hepatic function (>1.5 x ULN, ALAT and ASAT >2.5 x ULN)
- inadequate renal function (Creatinine clearance <50 ml/min)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 연구 인구
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Perioperative chemotherapy
Cytoreductive surgery
Hyperthermic intraperitoneal chemotherapy (HIPEC) with 100mg/m2 cisplatin
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Morbidity
기간: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
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Common Terminology Criteria for Adverse Events (CTCAE) ≥ grade 3
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From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
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Mortality
기간: From the day of surgery to 30 days postoperative
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Postoperative mortality
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From the day of surgery to 30 days postoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Survival
기간: Up to 5 years postoperative
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Overall and disease free survival
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Up to 5 years postoperative
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Recovery
기간: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
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ICU stay, hospital stay
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From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
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Quality of Life
기간: Up to 5 years postoperative
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EORTC-QLQ-C30 and EORTC-QLQ-STO22
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Up to 5 years postoperative
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Readmissions
기간: Up to 30 days after hospital discharge
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Readmissions after hospital discharge
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Up to 30 days after hospital discharge
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공동 작업자 및 조사자
수사관
- 수석 연구원: Richard van Hillegersberg, MD PhD, UMC Utrecht Cancer Center, Dep. of Surgery
- 수석 연구원: Jelle P Ruurda, MD PhD, UMC Utrecht Cancer Center, Dep. of Surgery
간행물 및 유용한 링크
일반 간행물
- Coccolini F, Cotte E, Glehen O, Lotti M, Poiasina E, Catena F, Yonemura Y, Ansaloni L. Intraperitoneal chemotherapy in advanced gastric cancer. Meta-analysis of randomized trials. Eur J Surg Oncol. 2014 Jan;40(1):12-26. doi: 10.1016/j.ejso.2013.10.019. Epub 2013 Nov 5.
- Glehen O, Gilly FN, Arvieux C, Cotte E, Boutitie F, Mansvelt B, Bereder JM, Lorimier G, Quenet F, Elias D; Association Francaise de Chirurgie. Peritoneal carcinomatosis from gastric cancer: a multi-institutional study of 159 patients treated by cytoreductive surgery combined with perioperative intraperitoneal chemotherapy. Ann Surg Oncol. 2010 Sep;17(9):2370-7. doi: 10.1245/s10434-010-1039-7. Epub 2010 Mar 25.
- Chia CS, You B, Decullier E, Vaudoyer D, Lorimier G, Abboud K, Bereder JM, Arvieux C, Boschetti G, Glehen O; BIG RENAPE Group. Patients with Peritoneal Carcinomatosis from Gastric Cancer Treated with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: Is Cure a Possibility? Ann Surg Oncol. 2016 Jun;23(6):1971-9. doi: 10.1245/s10434-015-5081-3. Epub 2016 Jan 11.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- NL58258.041.16
- 2016-002595-27 (EudraCT 번호)
- 16-180/G-M (기타 식별자: Ethical Review Board Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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