A randomised trial for gastric cancer with neo-adjuvant chemotherapy, chemoradiotherapy and surgery

Phase 1

• Conditions: TNM 7th ed stage IB-IIIC gastric adenocarcinoma (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction; MedDRA version: 19.0Level: LLTClassification code 10017759Term: Gastric cancer in situSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10017764Term: Gastric cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-004627-31-NL
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-29
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•TNM 7th ed stage IB-IIIC gastric adenocarcinoma (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction
•Performance status 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

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 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

•T1N0 disease (assessed by endoscopic ultrasound)
•Distant metastases
•Irresectable/Iinoperable 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-oesophageal stent within radiation field

Study & Design

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