Chemoradiation, Esophageal Cancer
Conditions
Brief summary
This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.
Interventions
RADIATIONRadiotherapy 54 Gy
Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.
RADIATIONRadiotherapy 60 Gy
Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.
DRUGS-1
S-1 70mg/m2 was administered on days 1-14 and 29-42.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Histological or cytologic diagnosis of esophageal carcinoma * ECOG performance status 0-1 * Age:70-85 years * Joined the study voluntarily and signed informed consent form * Patients must not have received any prior anticancer therapy * Stage Ⅰ-ⅣB（AJCC 2009） * Target lesions can be measured according to RECIST criteria * No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
Exclusion criteria
* Multiple carcinomas of the esophagus, * Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula, * Metastatic disease (M1b), * A primary tumor that extended to within 2 cm of the gastroesophageal junction, * Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor, * history of a second malignancy other than nonmelanoma skin cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | 2-year over survival |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | 5 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 5 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| the quality of life | 5 years | assessed with the European Organisation for Research and Treatment of Cancer quality-of-life core questionnaire QLQ-C30 |
| the oesophagus-specific quality-of-life | 5 years | assessed with the European Organisation for Research and Treatment of Cancer quality-of-life the oesophagus-specific questionnaire QLQ-OES18 |
Countries
China
Outcome results
None listed