Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma; ODM derived from:


Versions (1) ▾
  1. 5/24/16
Uploaded on:

May 24, 2016

No DOI assigned. To request one please log in.
Creative Commons BY 4.0
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Esophageal Carcinoma NCT00176800

Eligibility Esophageal Carcinoma NCT00176800

1. histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
2. no prior treatment for the esophageal cancer allowed.
3. no prior thoracic or upper abdominal radiation.
4. disease should be limited to the esophagus and regional lymph nodes. regional lymph nodes are described in section 4.0. however, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
5. disease must be able to be encompassed in a single radiation field.
6. no medical contraindication to surgery
7. all treatment is to be administered at the university of michigan medical center.
8. karnofsky performance status > 70 %.
9. age range: 18 - 75 years old.
10. adequate baseline hematopoetic function:
platelet count equal to or greater than 100,000/mm3 absolute granulocyte count equal to or greater than 1500/mm3 hematocrit equal to or greater than 29% (patients may be transfused to this level)
11. adequate baseline organ function :
creatinine clearance >/= 60 mls/min bilirubin equal to or less than 1.5 x upper limits of normal ast/alt equal to or less than 2.5 x upper limits of normal
12. patients with any complaint of hearing loss should be evaluated with an audiogram. the average pure tone average hearing loss from 500-2000hz should not exceed 30 db. if it does, the patient should be warned that further hearing loss may be very noticeable and permanent.
13. prior malignancy is acceptable if the patient is considered to be cured. in most cases this will mean a 5-year disease-free period. contact the principal investigator for any specific question regarding this requirement.
14. patients with active infection, serious inter-current medical conditions are ineligible, according to the judgment of the investigators.
15. pregnant or lactating females are not eligible. women of childbearing potential must be using contraception throughout the entire period of treatment.
16. ability to give informed consent.