Clinical trial NCT03150628: Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study
Official title: Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastric Cancer
Peritoneal Carcinomatosis
HIPEC
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Morbidity
timeFrame: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
measure: Mortality
timeFrame: From the day of surgery to 30 days postoperative
Secondary outcomes:
measure: Survival
timeFrame: Up to 5 years postoperative
measure: Recovery
timeFrame: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
measure: Quality of Life
timeFrame: Up to 5 years postoperative
measure: Readmissions
timeFrame: Up to 30 days after hospital discharge
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht Cancer Center, Dep. of Surgery
name: Richard van Hillegersberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht Cancer Center, Dep. of Surgery
name: Jelle P Ruurda, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.