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).

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50400

Enrollment

500

Registered

2006-09-05

Start date

2006-11-08

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer gastric carcinoma

Interventions

Chemoradiotherapy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 =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 • Serum creatinine = 60 ml/min (measured, or calculated by Cockcroft and Gault formula) and urinary excretion of 50% • Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis • Start treatment within 10 working days after registration • Written informed consent

Exclusion criteria

Exclusion criteria: • T1N0 disease (endoscopic ultrasound) • Distant metastases • Inoperable patients • 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

Design outcomes

Primary

Measure	Time frame
Survival.	—

Secondary

Measure	Time frame
Disease free survival Genomic prophyling and proteomics Quality of life Toxicity (NCI-CTC, version 3.0).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)