Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00220103
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years.
* Histologically verified adenocarcinoma of the thoracic oesophagus or type 1, 2 and 3 tumours of the oesophagogastric junction (type 1 refers to lower oesophageal, type 2 refers to cardial and type 3 refers to subcardinal cancers).
* AJCC Stage II-III (T2-3 N0-1 M0) (28), as assessed by spiral or multi-slice CT and endoscopic ultrasound, where primary surgery would be considered with curative intent.
* No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
* WHO performance status 0,1 or 2.
* Adequate bone marrow function with platelets \> 100 x 109/l; WBC \> 3 x 109/l; neutrophils \> 1.5 x 109/l at the time of study entry.
* Serum bilirubin \< 35 mol/l.
* Serum creatinine \< 180 mol/l and measured creatinine clearance over 60ml/min.
* No concurrent uncontrolled medical condition.
* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
* Life expectancy \> 3 months.
* Adequate contraceptive precautions if relevant.
* Informed written consent.
Exclusion Criteria:
* The presence of locally advanced or metastatic disease precluding curative surgical resection (T4 or Stage IV or M1a-b)
* Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Patients with disease in any of the following areas on the basis of CT scan and/or endoscopic ultrasound:
* Evidence of liver, lung or other distant metastases
* Para-aortic/coeliac lymphadenopathy \> 1cm diameter on CT, \> 6mm diameter on EUS
* Invasion of airways, aorta, pericardium, or lung
* New York Heart Association classification Grade III or IV.
* Uncontrolled angina pectoris.
* Pregnancy or breast feeding.
* Impaired renal function with measured creatinine clearance less than 60 ml/min.
* Known malabsorption syndromes.
* Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00220103
Study Brief:
Protocol Section:
NCT00220103