ISRCTN45750457CompletedNot Applicable

Accuracy of FDG-PET and spiral CT for the early prediction of non-response to preoperative chemoradiotherapy in patients with oesophageal cancer

Academic Medical Centre (AMC) (Netherlands)0 sites150 target enrollmentStarted: December 20, 2005Last updated: January 13, 2015

Conditions

Trial Snapshot

No summary available.

•1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic oesophagus.
•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 <8 cm and radial < 5 cm
•4. If the tumor extends below the gastroesophageal(GE) junction into the
•proximal stomach, the bulk of the tumor must involve the oesophagus or
•GE junction. The tumor must not extend > 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 <18 and >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 x ULN
•12. Creatinine <120 µmol/L
•13. FEV1 > 1,5 L
•14. Written, voluntary informed consent.
•15. Patients must be accessible to follow up and management in the treatment center.
•16. Patients must sufficiently understand the Dutch language to fill in quality of life questionnaires

•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
•4. Documented myocardial infarction within 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients)
•5. Patients with a history of significant ventricular arrhythmia requiring medication or
•congestive heart failure History of 2nd or 3rd degree heart blocks
•6. Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
•7. 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
•8. Dementia or altered mental status that would prohibit the understanding and giving of informed consent
•9. Inadequate caloric- and/ or fluid intake
•10. Weight loss > 10%

Sponsor

Academic Medical Centre (AMC) (Netherlands)