gastric cancer
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • T4 tumors (extension into the esophagus is acceptable as long as the bulk (>50%) of the tumor is in the stomach), and/or N2 nodes > 7 suspected nodes on EUS or CT scan, and/or one large lymph node (mass or conglomerate), and/or > 3 suspected lymph nodes in truncus / para-aortal / spleen hilus. All lymphnodes have to be in cranial position of the renal arteries (in other words tumors that are not suitable for participation in the CRITICS (M06CRI) study) * stage Ib-IVa (no distant metastases) gastric cancer (histologically confirmed); tumor bulk has to in the stomach but may involve the gastro-esophageal junction • WHO 6.5 mmol/l; leukocytes>3.5x109/l, neutrophils > 1.5x109/l, thrombocytes > 100 x 109/l • Renal function: serum creatinine 60 ml/min (measured, or calculated by Cockcroft and Gault formula) • Liver function: total bilirubin
Exclusion criteria
Exclusion criteria: • Distant metastasis; i.e. lymph node metastasis that are encompassed in the radiation portals are acceptable • Suspected lymph nodes below the renal arteries • Inoperable patients; due to technical surgery-related aspects or general condition (ASA III or IV) • Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri. In case of other malignancies, the patients has to be disease-free for * 5 years to be eligible • Previous radiotherapy involving the planned treatment field or compromising bone marrow reserve • Previous chemotherapy except adjuvant chemotherapy for e.g. breast or coloncarcinoma, if * 5 years before • Uncontrolled (bacterial) infections • Significant non-malignant disease which in the opinion of the study coordinators is incompatible with the protocol • Neurotoxicity > CTC grade 1 • Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy (resectability rate, pCR rate, R0 rate) and safety | — |
Secondary
| Measure | Time frame |
|---|---|
| • Disease free survival and overall survival • To investigate if PET (positron emission tomography) imaging before, during and after chemoradiotherapy can predict pathological response • Collect tissue and serum before chemoradiotherapy for genomic profiling and proteomics to detect tumor recurrence risk patterns in gastric cancer | — |
Countries
Netherlands
Outcome results
None listed