Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)

• Status: Active, not recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dutch Colorectal Cancer Group
• Collaborators: Roche Pharma AG; The Netherlands Cancer Institute
• Treatments: Capecitabine; Cisplatin; Epirubicin

Criteria

Inclusion Criteria:

• Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk in the stomach

• WHO < 2

• Age ≥18 yrs

• Operable gastric cancer

• No prior abdominal radiotherapy or chemotherapy

• Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis

• Start treatment within 10 working days after registration

• Written informed consent

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 cardiac disorders

• Continuous use of immunosuppressive agents

• Concurrent use of the antiviral agent sorivudine or chemically related analogues

• Hearing loss > CTC grade 1

• Neurotoxicity > CTC grade 1