Status:
COMPLETED
Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Esophageal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Surgery has been the standard of care for esophageal cancer for many years, with limited success. At present, several studies are underway nationwide which utilize chemotherapy combined with radiation...
Detailed Description
The pre-study evaluations include a medical history, physical examination, blood laboratory evaluations, and scans to evaluate disease. A CT scan will be performed to measure the size of the subject's...
Eligibility Criteria
Inclusion
- Eligibility Requirements
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
- No prior treatment for the esophageal cancer allowed.
- No prior thoracic or upper abdominal radiation.
- 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.
- Disease must be able to be encompassed in a single radiation field.
- No medical contraindication to surgery
- All treatment is to be administered at the University of Michigan Medical Center.
- Karnofsky Performance Status (scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 100% where 100% represents perfect health and 0 represents death) \> 70 %.
- Age range: 18 - 75 years old.
- 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)
- Adequate baseline organ function :
- Creatinine clearance \>/= 60 mls/min Bilirubin equal to or less than 1.5 x upper limits of normal AST (aspartate aminotransferase)/ALT (alanine aminotransferase) equal to or less than 2.5 x upper limits of normal
- 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.
- 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.
- Patients with active infection, serious inter-current medical conditions are ineligible, according to the judgment of the investigators.
- Pregnant or lactating females are not eligible. Women of childbearing Potential must be using contraception throughout the entire period of treatment.
- Ability to give informed consent.
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00176800
Start Date
November 1 2001
End Date
May 1 2013
Last Update
August 22 2016
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109