Esophageal Cancer Clinical Trial
Official title:
A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER: CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL
Verified date | July 2013 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation
therapy in treating patients with cancer of the esophagus.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 2000 |
Est. primary completion date | October 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed epidermoid carcinoma or adenocarcinoma
of the esophagus eligible for potentially curative radiotherapy Disease in one of the
following categories: Newly diagnosed Locoregional failure after prior resection with
curative intent Positive microscopic margin after palliative resection of all gross
disease Disease clinically limited to esophagus T 1-4, any N, M0 Gastroesophageal junction
tumor allowed No positive pleural, pericardial, or peritoneal cytology No tracheobronchial
invasion on bronchoscopy, including tracheoesophageal fistula PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: WBC more than 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 65 mL/min per 1.73 square meters Cardiovascular: No NYHA class 3/4 status No cerebral vascular disease No hypertension Other: No severe uncontrolled diabetes No uncontrolled infection No other medical condition that precludes treatment No mental status abnormality that precludes comprehension of or compliance with treatment No active cancer arising at another primary site other than basal cell carcinoma of the skin or in situ cervical carcinoma PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) |
United States,
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