gastric cancer
Conditions
Interventions
Intervention is the use of chemoradiotherapy as an adjunct to the standard
surgical resectioen. As adjuvant chemoradiation has some disadvantages such as
an improved possibilty to abandon chemoradio
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically proven and documented adenocarcinoma of the stomach - Surgical resectable gastric cancer stage IB-IVA: T1N1; T2-4, N0-1, M0 ( see appendix), as determined by Endoscopic Ultra Sound (EUS), Computed Tomography (CT). - Age >= 18 and = 4.0 x 109/L - Platelet count >= 100 x 109/L - Serum bilirubin =50 ml/min (cockcroft formula) -Two equally functioning kidneys determined with standard technology (renogram) - Tumor negative laparoscopy when CT suggests peritoneal carcinomatosis - Written, voluntary informed consent (interval between information and consent at least 7 days) - Patients must be accessible to follow up and management in the treatment center - Patients must sufficiently understand the Dutch language and must be able to sign the informed consent document.
Exclusion criteria
Exclusion criteria: - T1N0 tumors and in situ carcinoma (endoscopic ultrasound) are not eligible - Distant metastases - In case of only one functional kidney - Previous or current malignancies at other sites than entry diagnosis except for adequately treated basal or squamous cell carcinoma of the skin, or curatively treated carcinoma in situ of the cervix uteri - Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy, or prior esophageal or gastric surgery. - Evidence of serious active infections - Severe cardiac and/or pulmonary failure, uncontrolled hypertension, angina pectoris - Clinical signs of myocardial ischaemia - Dementia or altered mental status that would prohibit the understanding and giving of informed consent - Pregnant or lactating women. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the possible delay in performing a curative resection due to increased toxicity of more than 10% with a stopping point at a delay in six patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are : - efficacy - occurence of downstaging and changes in pathology | — |
Countries
Netherlands
Outcome results
None listed