A study designed to compare the effect of two treatment types in gastric cancer patients with peritoneal metastasis, standard systemic chemotherapy vs surgery combined with hyperthermic chemotherapy in the abdominal cavity.

Phase 1

• Conditions: Gastric cancer with peritoneal carcinomatosis or tumour positive cytology; MedDRA version: 20.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 100000004856; MedDRA version: 21.0Level: PTClassification code 10061269Term: Malignant peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10057647Term: Cytoreductive surgerySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10067093Term: Intraperitoneal hyperthermic chemotherapySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10061965Term: GastrectomySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005695-15-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-14
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

- Age = 18 years
- cT3-cT4 adenocarcinoma (or undifferentiated carcinoma) of the stomach, considered to be resectable
- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology (proven by laparoscopy or laparotomy)
- Absence of disease progression during prior systemic chemotherapy
- WHO performance status 0-2
- Adequate bone marrow, hepatic and renal function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

- Distant metastases or small bowel dissemination
- Recurrent gastric cancer
- Prior resection of the primary gastric tumour
- Non-synchronous peritoneal carcinomatosis
- Current other malignancy (other than cervix carcinoma and basalioma)
- Hepatitis B or C, known HIV infection or an uncontrolled infectious disease
- Recent myocardial infarction (< 6 months) or unstable angina
- Uncontrolled diabetes mellitus
- Pregnancy or breast feeding
- Any medical condition that is considered to interfere with study procedures and/or would jeopardize safe treatment
- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified