Gastric cancer Neoadjuvant chemotherapy Maagkanker Neoadjuvante chemoradiatie
Conditions
Interventions
Intervention is the use of chemoradiotherapy as an adjunct to the standard surgical resection. As adjuvant chemoradiation has soms disadvantages such as an improved possibility to abandon chemoradioth
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven and documented adenocarcinoma of the stomach; 2. 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); 3. Age ¡Ý18 and ¡Ü75; 4. Ambulatory performance status (WHO scale 0-2(see appendix); 5. No prior chemotherapy; 6. No prior radiotherapy; 7. If more than 50% of the tumor extends above the gastroesophageal (GE) junction into the esophagus, the bulk of the tumor must involve the stomach. The tumor must not extend more than 2 cm into esophagus; 8. Adequate hematological, renal and hepatic functions defined as: a. White blood cell count ¡Ý4.0 x 109/L; b. Platelet count ¡Ý100 x 109/L; c. Serum bilirubin ¡Ü 1.5 x upper normal limit; d. Calculated Creatinine Clearance ¡Ý50 ml/min (cockcroft formula); e. Two equally functioning kidneys determined with standard technology(renogram); 9. Tumor negative laparoscopy when CT suggests peritoneal carcinomatosis; 10. Written, voluntary informed consent (interval between information and consent at least 7 days); 11. Patients must be accessible to follow up and management in the treatment center; 12. Patients must sufficiently understand the Dutch language and must be able to sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. T1N0 tumors and in situ carcinoma (endoscopic ultrasound) are not eligible; 2. Distant metastases; 3. In case of only one functional kidney; 4. 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; 5. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy, or prior esophageal or gastric surgery; 6. Evidence of serious active infections; 7. Severe cardiac and/or pulmonary failure, uncontrolled hypertension, angina pectoris; 8. Clinical signs of myocardial ischaemia; 9. Dementia or altered mental status that would prohibit the understanding and giving of informed consent; 10. 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 occurrence of downstaging and changes in pathology (pathological responses). Tissue and serum before and after treatment for genomic profiling, kinome profiling (kinase activity) and protein expression will be collected to determine patterns to predict response to therapy. 1. To determine pathological responses; 2. To determine genomic profile to predict response to treatment; 3. To determine the number of R0 resections; 4. To determine progression free survival; 5. To detect risk of tumor recurrence patterns. Furthermore we will assess quality of life (QOL) before, during and after this combined treatment. | — |
Contacts
Public ContactG.A.P. Hospers
Dept. of Medical Oncology University Medical Center Groningen PO Box 30.001
Outcome results
None listed