Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study

Gastric Cancer Clinical Trial

— CISCA  

Official title:

Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03150628
• Other study ID #: NL58258.041.16
• Secondary ID: 2016-002595-2716
• Status: Terminated
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: April 23, 2018

Study information

• Verified date: April 2019
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 23, 2018
• Est. primary completion date: April 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Gastric Cancer
• HIPEC
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Perioperative chemotherapy
Perioperative chemotherapy

Procedure:
• Cytoreduction
Cytoreductive surgery

Drug:
• HIPEC
Hyperthermic intraperitoneal chemotherapy (HIPEC) with 100mg/m2 cisplatin

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Richard van Hillegersberg

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View 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. Review. — View Citation

Glehen O, Gilly FN, Arvieux C, Cotte E, Boutitie F, Mansvelt B, Bereder JM, Lorimier G, Quenet F, Elias D; Association Française 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Common Terminology Criteria for Adverse Events (CTCAE) = grade 3	From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
Primary	Mortality	Postoperative mortality	From the day of surgery to 30 days postoperative
Secondary	Survival	Overall and disease free survival	Up to 5 years postoperative
Secondary	Recovery	ICU stay, hospital stay	From the day of surgery to hospital discharge or 30 days postoperative, whichever is last
Secondary	Quality of Life	EORTC-QLQ-C30 and EORTC-QLQ-STO22	Up to 5 years postoperative
Secondary	Readmissions	Readmissions after hospital discharge	Up to 30 days after hospital discharge