Esophagus Squamous Cell Carcinoma
Conditions
Keywords
Esophageal neoplasma, adjuvant therapy, raltitrexed, radiotherapy
Brief summary
Concurrent chemoradiotherapy is one of the curative options for esophageal squamous cell carcinoma. We evaluated the efficacy and toxicity of raltitrexed with concurrent radiotherapy in elderly patients with esophageal cancer.
Interventions
DRUGraltitrexed
Raltitrexed 2.6mg/m2 was administered on d1、d22
Sponsors
Huai'an First People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 IIa-Ⅳa(AJCC 2002). 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(OS) | 3 years | From the date of randomization until the date of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 3 years | From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause |
| treatment-related toxicities | From the date of randomization until six months after treatment completion | Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0 |
| Quality of life(QOL) | 3 years | QOL is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after treatment among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) |
Countries
China
Outcome results
None listed