Preoperative intraperitoneal chemotherapy in adjuvant hyperthermiaadjunctive therapy in advanced gastric cancer with high-risk of peritoneal recurrence - a multicentre randomized trial
- Conditions
- Gastric CarcinomaMedDRA version: 21.0Level: LLTClassification code 10007350Term: Carcinoma gastricSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-001419-25-PL
- Lead Sponsor
- Jagiellonian University Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
- gastric cancer confirmed in histological examination of material taken during gastroscopy and biopsy of the tumour
- advanced gastric cancer (cT3/T4a, cN0-3b)
- no distant metastases on chest, abdominal and pelvic computed tomography (cM0)
- age 18-75
- signed written informed consent
-completion of at least 3 cycles of preoperative FLOT chemotherapy
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 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240
- lack of confirmation of gastric cancer in histologic examination of biopsy material taken during gastroscopy
- age > 75
- Performance status 3 or higher in ECOG/WHO scale
- previous abdominal surgery other than appendectomy or laparoscopic cholecystectomy
- pregnancy or lactation
- lack of written informed consent
- other simultaneous neoplasm
- previous systemic treatment or radiotherapy for other neoplasm
- serious dysfagia requiring surgical treatment before previous chemotherapy
- lack of qualification to perioperative chemotherapy by multidisciplinary team (MDT)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method