NeoRes
/1. Registration Form
/ Page 1 (1)Study protocol for the resectable cancer of the esophagus and gastro-esophageal junction.
INSTRUCTIONS:Enter form data into the NeoRes database and retain the copy for patient records.
Patient identification
1.Registration date /
/ (DDMMYYYY)
2. Centre (Hospital name)
3.Patient birth date /
/ (DDMMYYYY)
4. Patient initials /
Inclusion criteria
•Histologically verified squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia (typ II) / Yes No
•Tumour located in cervical oesophagus, not requiring laryngo-esophagectomy / Yes No
•Tumour stage T1N1, T2N0, T2N1, T3N0, T3N1, M1a / Yes No
•Performance status (WHO) of 0–1 / Yes No
•Age 75 years / Yes No
•Adequate hematological function defined as WBC 3 x 109/L and platelets 100 x 109/L / Yes No
•Adequate renal function defined as creatinine clearence 60 ml/min / Yes No
•No major illness that make chemoradiotherapy unsuitable, life expectancy at least 3 months / Yes No
•Signed informed consent form / Yes No
Exclusion criteria
•Pregnancy and /or lactation / Yes No
•Patients with diabetes complications (e.g. retinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocardial infarction within 12 months are considered unsuitable for chemoradiotherapy. / Yes No
•Concomitant malignancy (<5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment. / Yes No
•Patients being unable to comply with the protocol / Yes No
•Tumour stage T1N0, T4Nx or TxNxM1b / Yes No
Investigator’s signature, date: /
Stratification: / T– stage:
T1 T2 T3 / N– stage:
N0 N1
Tumor location: / Prox esophagus Distal eusophagus
Mid esophagus Cardia (type II) / Histology
SCC
Adenocarcinoma
Registration
Patient registration number /
/ Allocated treatment:
Arm A: Chemoradiation + surgery
Arm B: Chemotherapy + surgery
Signature of person completing randomization; date /
NeoRes, 080227. version 2; 091104