Multicentric Randomised Trial for Resectable Gastric Cancer

• Status: Recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts:

• Preoperative treatment is associated with better patient compliance than postoperative regimens

• Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections

• Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Capecitabine; Carboplatin; Docetaxel; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

• TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction

• WHO < 2

• Age ≥ 18 yrs

• Resectable adenocarcinoma of the stomach or gastro-oesophageal junction

• No prior abdominal radiotherapy

• Haematology: Hb ≥5.0 mmol/l; leukocytes≥3.0x109/l, neutrophils ≥1.5x109/l, thrombocytes ≥100x109/l

• Renal function: serum creatinine ≤1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula) Liver function: total bilirubin ≤1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN

• At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial free peritoneal fluid if any should be pathologically proven tumor negative

• Written informed consent

• Expected adequacy of follow-up

• Caloric intake≥1500 kcal/day, verified by a dietician before registration.

• if caloric intake is < 1500 kcal/day or if bodyweight has decreased > 10% over the last 6 months or > 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory

Exclusion Criteria:

• T1N0 disease (assessed by 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; in case of a previous other malignancy with a disease-free period≥5 years, inclusion can be accepted after consultation of the principal investigator

• 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 arrhythmias

• Continuous use of immunosuppressive agents equivalent to >10 mg daily prednison

• Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine

• Neurotoxicity > CTC grade 1

• Pregnancy or breast feeding

• Patients (M/F) with reproductive potential not implementing adequate contraceptive measures

• Gastric or gastro-esophageal stent within radiation field