drugset / Trial / NCT03348150
Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination.
Phase 3
Active not recruiting
102 enrolled
The Netherlands Cancer Institute
Catharina Ziekenhuis Eindhoven · collabErasmus Medical Center · collabUMC Utrecht · collabUniversity Medical Center Groningen · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm).
Timeline
- Start
- 2017-10-01
- Primary completion
- 2025-09-17
- Completion
- 2027-10-01
Outcome
Missed primary endpoint
paper Median overall survival in the standard group was 16·6 months (95% CI 14·1-21·9), compared with 15·7 months (11·4-25·5) in the experimental group (hazard ratio 1·10 [95% CI 0·69-1·74]; p=0·70). PMID 42419336 ↗
paper Gastrectomy with cytoreductive surgery and HIPEC provided no survival benefit in patients with gastric cancer and limited peritoneal metastases compared with systemic therapy alone. PMID 42419336 ↗
Publications
- Background van der Kaaij RT, Braam HJ, Boot H, Los M, Cats A, Grootscholten C, Schellens JH, Aalbers AG, Huitema AD, Knibbe CA, Boerma D, Wiezer MJ, van Ramshorst B, van Sandick JW. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790.
- Quik JSE, Vollebergh MA, Retel VP, van der Sluis K, Koemans WJ, van der Kaaij RT, Voets MM, Luyer MDP, van Hellemond IEG, Wijnhoven BPL, Mostert B, van Hillegersberg R, Mohammad NH, van Etten B, de Groot DJ, Helminen O, Hedberg J, Cashin PH, Harbjerg JL, Veenhof AAFA, Hartemink KJ, Kodach LL, van der Noort V, van Sandick JW; PERISCOPE II consortium. Systemic therapy, gastrectomy, cytoreductive surgery, and hyperthermic intraperitoneal chemotherapy versus systemic therapy alone for gastric cancer with limited peritoneal metastases (PERISCOPE II): final results of a multicentre, randomised, controlled, phase 3 trial after an unplanned commissioned interim analysis. Lancet Oncol. 2026 Jul 8:S1470-2045(26)00144-0. doi: 10.1016/S1470-2045(26)00144-0. Online ahead of print.
- Rijken A, Pape M, Simkens GA, de Hingh IHJT, Luyer MDP, van Sandick JW, van Laarhoven HWM, Verhoeven RHA, van Erning FN. Peritoneal metastases from gastric cancer in a nationwide cohort: Incidence, treatment and survival. Int J Cancer. 2024 Mar 15;154(6):992-1002. doi: 10.1002/ijc.34780. Epub 2023 Nov 2.
- Koemans WJ, van der Kaaij RT, Boot H, Buffart T, Veenhof AAFA, Hartemink KJ, Grootscholten C, Snaebjornsson P, Retel VP, van Tinteren H, Vanhoutvin S, van der Noort V, Houwink A, Hahn C, Huitema ADR, Lahaye M, Los M, van den Barselaar P, Imhof O, Aalbers A, van Dam GM, van Etten B, Wijnhoven BPL, Luyer MDP, Boerma D, van Sandick JW. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II). BMC Cancer. 2019 May 6;19(1):420. doi: 10.1186/s12885-019-5640-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 50 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 460 mg/m2 | Other |