A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer (CRITICS-study: ChemoRadiotherapy after Induction chemoTherapy In Cancer of the Stomach) - CRITICS

Conditions: Resectable gastric cancer
MedDRA version: 8.1Level: LLTClassification code 10017758Term: Gastric cancer

Registration Number: EUCTR2006-004130-32-DK

Lead Sponsor: KI/Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk has to be in the stomach but may involve gastro-esophageal junction
• WHO < 2
• age =18 yrs
• Operable gastric cancer
• No prior abdominal radiotherapy or chemotherapy
• Hematology: Hb > 5.0 mmol/l; leukocytes > 3.0x109/l, neutrophils > 1.5x109/l, thrombocytes > 100 x 109/l
• Renal function: serum creatinine = 1.25 ULN, creatinine clearance > 60 ml/min (measured, or calculated by Cockcroft and Gault formula) and urinary excretion of = 1.0 gram protein/24 hours
• Liver function: total bilirubin =1.5x ULN, Alkaline phosphatase and ASAT/ALAT = 3x ULN
• Left ventricular ejection fraction > 50%
• Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis
• Written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• T1N0 disease (endoscopic ultrasound)
• Distant metastases
• Inoperable patients; due to technical surgery-related factors or general condition
• Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri.
• Solitary functioning kidney that will be within the radiation field
• Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
• Uncontrolled (bacterial) infections
• Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
• Uncontrolled angina pectoris; cardiac failure or clinically significant arrhytmias
• Continuous use of immunosuppressive agents
• Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
• Hearing loss > CTC grade 1
• Neurotoxicity > CTC grade 1
• Pregnancy or breast feeding
• Patients (M/F) with reproductive potential not implementing adequate contraceptive measures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether postoperative chemoradiotherapy prolongs overall survival compared to postoperative chemotherapy in patients that have had adequate stomach surgery following preoperative chemotherapy;Secondary Objective: To assess whether postoperative chemoradiotherapy prolongs disease free survival compared to postoperative chemotherapy in patients that have had adequate stomach surgery following preoperative chemotherapy<br>To collect tissue and serum before treatment for genomic profiling and proteomics to detect tumor recurrence risk patterns in gastric cancer<br>To determine a genomic profile and classifier to predict response to therapy <br>To assess the value of Maruyama-index and predictive nomograms for disease recurrence (36;37)<br>To compare health-related quality of life (HRQL) of both treatment regimens;Primary end point(s): Overall survival

Secondary Outcome Measures

Name	Time	Method

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