Esophageal cancer
Conditions
Interventions
150 consecutive patients will be included in this prognostic accuracy study over a 3 year period. FDG-PET and CT-scan will be performed independently before and 2 weeks after the start of the chemora
Sponsors
Academic Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus; 2. Surgical resectable (T2-3, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS); 3. T1N1 are eligible. (T1N0 tumors and tumors in situ are not elligible). Tumor length longitudinal 2 cm into the stomach. Gastric cancers with minor involvement of the GE junction or distal esophagus are not eligible; 5. No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula; 6. Non pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy; 7. Age 75; 8. ECOG performance status of 0-2; 9. Granulocytes > 1.5 x 109/l; 10. Platelets > 100 x 109/l; 11. Total bilirubin 1,5 L; 14. Written, voluntary informed consent; 15. Patients must be accesssible to follow up and management in the treatment center; 16. Patients must sufficiently understand the Dutch language to fill in quality of life questionnaires.
Exclusion criteria
Exclusion criteria: 1. Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated carcinoma in situ of the cervix or a “cured”malignancy more than 5 years prior to enrollment; 2. Previous chemotherapy and radiotherapy; 3. New York Heart Association Class lll/lV and no history of active angina. Documented myocardial infarction within 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication or congestive haert failure. History of 2nd or 3rd degree heart blocks; 4. Pre-existing motor or sensory neurotoxicity greater than WHO grade 1; 5. Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporin; 6. Dementia or altered mental status that would prohibit the understanding and giving of informed consent; 7. Inadequate caloric- and/ or fluid intake; 8. Weight loss > 10%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The accuracy of serial FDG-PET and CT-scan for the early prediction of response versus non-response to preoperative chemoradiotherapy. The negative predictive value of serial FDG-PET and CT-scan for non-response. These primary endpoints will quantify the diagnostic potential and clinical applicability / usefulness of each technique to predict early treatment response. | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation between histological tumor response in the resection specimen and long term survival. | — |
Contacts
Public ContactJ.M.T. Omloo
Academic Medical Center (AMC), Department of Surgery P.O. Box 22660
Outcome results
None listed