Status:
COMPLETED
Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add ...
Eligibility Criteria
Inclusion
- Patient Eligibility:
- Histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction.
- Disease limited to the esophagus and regional lymph nodes. 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 \> 60%
- Ages 18-75
- Adequate renal function (BUN \<1.5 x N; creatinine \<1,5 mg/dl, or measured creatinine clearance\>60 ml/min.).
- Adequate bone marrow reserve (WBC\>3500/ul; Platelets\>100,000/ul.).
- Adequate hepatic function (Bilirubin\<1.5x N; AST \<2 x upper limit of normal).
- Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5 year disease-free period.
- Ability to give informed consent.
- Exclusion Criteria:
- Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
- No prior treatment allowed. No prior thoracic radiation.
Exclusion
Key Trial Info
Start Date :
November 1 1997
Trial Type :
INTERVENTIONAL
End Date :
July 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00230451
Start Date
November 1 1997
End Date
July 1 2008
Last Update
January 15 2010
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48197