Esophageal Cancer
Conditions
Keywords
S-1, radiation, esophageal Cancer
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)/day.
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 esophageal Cancer. Methods:S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day. Thoracic radiation therapy was administered in 1.8Gy fractions five times weekly to a total dose of 54 Gy.
Interventions
DRUGS-1
S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer | 3 months per patient | the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]). | dependent upon results |
Countries
China
Outcome results
None listed