Esophageal Squamous Cell Carcinoma
Conditions
Keywords
esophageal neoplasma, adjuvant therapy, chemotherapy, radiotherapy
Brief summary
The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.
Interventions
cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks
RADIATIONradiotherapy
radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)
Sponsors
The Second People's Hospital of Huai'an
lian shui county People's Hospital
xuyi People's Hospital
Chinese People's Liberation Army No. 82 Hospital
Huai'an First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. biopsy-confirmed esophageal squamous cell carcinoma 2. age ≤ 70 years old, 3. Karnofsky performance status ≥ 70, 4. R0 esophagectomy according to the pathological examination of the resected specimens, 5. postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma 6. Adequate organ functions (1).white blood cell (WBC) ≥3×109⁄L; (2).Absolute neutrophil counts (ANC) ≥1.5×109⁄L; (3).Hemoglobin (Hb) ≥10g⁄dl; (4).Platelet (Plt) ≥100×109⁄L; (5).Total bilirubin \<1.5 upper limit of normal (ULN); (6).Aspartate transaminase (AST) ≤2.5 ULN; (7).Alanine aminotransferase (ALT) ≤2.5 ULN; (8).Creatinine ≤1.5 ULN; (9).adequate pulmonary function (FEV1\>0.8 L;. 7. no previous treatment or severe complications 8. Written informed consent
Exclusion criteria
1. previous treatment with chemotherapy or radiotherapy 2. greater than 3 months after surgery 3. complete esophageal obstruction after surgery, esophageal perforation; 4. other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years; 5. pregnant or breast-feeding women； 6. patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease； 7. drug addiction, Alcoholism or AIDS; 8. uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; 9. with clear chemotherapy drug allergy 10. participation in other interventional clinical trials within 30 days;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From date of randomization to death from any cause, assessed up to 3 years | From the date of randomization until the date of death |
| 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) | 1 year | Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months. |
Countries
China
Outcome results
None listed