A multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery vs. neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery vs. neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer

Phase 2

Recruiting

• Conditions: stomach cancer; gastric cancer; 10017990; 10017991

• Registration Number: NL-OMON53113
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 207

Inclusion Criteria

• TNM 8th ed 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
• Start treatment within 15 working days after randomisation
• 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 endoscopic ultrasound
• Distant metastases
• Irresectable 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Event-free survival at 1 year after randomisation (events: local recurrence,<br /><br>regional recurrence, local-regional recurrence or progression, distant<br /><br>recurrence, or death from any cause).</p><br>