BridgeMD
CRITICS-II
EU CTIS ID: 2023-503248-15-00
What this study is testing
To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectablegastric cancer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- TNM 8th ed IB- IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involvegastro-oesophageal junction
- 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
- WHO < 2
You likely can't join if
- T1N0 disease endoscopic ultrasound
- 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
See the full eligibility criteria
- TNM 8th ed IB- IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involvegastro-oesophageal junction
- 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
- 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 freeperitoneal fluid if any should be pathologically proven tumor negative
- T1N0 disease endoscopic ultrasound
- 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
- 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 afterconsultation 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 majorsurgery
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.