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 @ 11:54 AM
Ignite Modification Date:
2025-12-24 @ 11:54 AM
NCT ID:
NCT00509561
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed carcinoma of the esophagus
* Adenocarcinoma
* Squamous cell
* Undifferentiated carcinoma
* Siewert type I tumor of the gastroesophageal junction
* Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and spiral CT scan
* Total disease length (primary and lymph nodes) \< 10 cm by EUS
* Not suitable for surgery (either for medical reasons or patient's choice)
* No metastatic disease (i.e., M1a or M1b according to UICC TNM version 6)
* No significant (\> 2 cm) extension of tumor into the stomach
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* White blood cell count ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL (should be corrected to \> 10 g/dL before treatment)
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT/AST ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Glomerular filtration rate \> 40 mL/min OR \> 60 mL/min estimated by Cockcroft-Gault formula
* Adequate cardiac ejection fraction ≥ 40% by MUGA or ECHO
* FEV\_1 ≥ 1 L by spirometry
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No malignancy within the past 5 years
* No unstable angina, uncontrolled hypertension, cardiac failure, or other clinically significant cardiac disease
* No major trauma within the past 4 weeks
* No known dihydropyrimidine dehydrogenase deficiency
* No hearing impairment or sensory-motor neuropathy \> grade 2
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior sorivudine and analogues
* At least 4 weeks since prior major surgery
* At least 4 weeks since prior monoclonal antibody
* At least 3 months since prior radiotherapy
* No prior treatment for invasive esophageal carcinoma or gastroesophageal junction carcinoma (not including photodynamic therapy or laser therapy for high-grade dysplasia/carcinoma in situ)
* No other prior treatment for this malignancy that would compromise the ability to deliver definitive mediastinal chemoradiotherapy or compromise survival
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00509561
Study Brief:
Protocol Section:
NCT00509561