Status:
COMPLETED
S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
70-85 years
Phase:
PHASE1
Brief Summary
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/...
Detailed Description
Purpose:evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase II study when administered concurrently with thoracic radiation in elderly patients (\>70 years old) with es...
Eligibility Criteria
Inclusion
- Histologically documented diagnosis of esophageal Cancer
- Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible
- age:70-85 years
- Written informed consent.
- Performance status of 0 to 2
- Neutrophil count \>1.5 x 10 to the 9th power/L and platelets \> 100 x 10 to the 9th power/L.
- Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement
- Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
Exclusion
- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy or radiation therapy for esophageal cancer
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01175447
Start Date
February 1 2010
End Date
December 1 2011
Last Update
March 6 2012
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022