- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
-
Utrecht, Nederländerna, 3584 CX
- University Medical Center Utrecht
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Studera befolkning
|
Perioperative chemotherapy
Cytoreductive surgery
Hyperthermic intraperitoneal chemotherapy (HIPEC) with 100mg/m2 cisplatin
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Morbidity
Tidsram: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
|
Common Terminology Criteria for Adverse Events (CTCAE) ≥ grade 3
|
From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
|
Mortality
Tidsram: From the day of surgery to 30 days postoperative
|
Postoperative mortality
|
From the day of surgery to 30 days postoperative
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Survival
Tidsram: Up to 5 years postoperative
|
Overall and disease free survival
|
Up to 5 years postoperative
|
Recovery
Tidsram: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
|
ICU stay, hospital stay
|
From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
|
Quality of Life
Tidsram: Up to 5 years postoperative
|
EORTC-QLQ-C30 and EORTC-QLQ-STO22
|
Up to 5 years postoperative
|
Readmissions
Tidsram: Up to 30 days after hospital discharge
|
Readmissions after hospital discharge
|
Up to 30 days after hospital discharge
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Richard van Hillegersberg, MD PhD, UMC Utrecht Cancer Center, Dep. of Surgery
- Huvudutredare: Jelle P Ruurda, MD PhD, UMC Utrecht Cancer Center, Dep. of Surgery
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Peritoneala sjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i buken
- Neoplasmer i magen
- Carcinom
- Peritoneala neoplasmer
Andra studie-ID-nummer
- NL58258.041.16
- 2016-002595-27 (EudraCT-nummer)
- 16-180/G-M (Annan identifierare: Ethical Review Board Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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