Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma
This study has been completed.
Information provided by:
University of Michigan Cancer Center
First received: September 28, 2005
Last updated: January 14, 2010
Last verified: January 2010
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 benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma
Primary Outcome Measures:
- To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
Secondary Outcome Measures:
- To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
- To assess the qualitative and quantitative toxicities of this regimen.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 1999 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230451
|University of Michigan Cancer Center
|Ann Arbor, Michigan, United States, 48197 |
University of Michigan Cancer Center
||Susan Urba, M.D.
||University of Michigan Cancer Center
No publications provided
||Susan G. Urba, M.D., University of Michigan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2005
||January 14, 2010
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic