Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Radiation: radiotherapy
- Registration Number
- NCT03600831
- Lead Sponsor
- Huai'an First People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 434
- biopsy-confirmed esophageal squamous cell carcinoma
- age ≤ 70 years old,
- Karnofsky performance status ≥ 70,
- R0 esophagectomy according to the pathological examination of the resected specimens,
- postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
- 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;.
- no previous treatment or severe complications
- Written informed consent
- previous treatment with chemotherapy or radiotherapy
- greater than 3 months after surgery
- complete esophageal obstruction after surgery, esophageal perforation;
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- pregnant or breast-feeding women；
- patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease；
- drug addiction, Alcoholism or AIDS;
- uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- with clear chemotherapy drug allergy
- participation in other interventional clinical trials within 30 days;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description radiotherapy group radiotherapy All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week). concurrent chemoradiotherapy group Docetaxel plus cisplatin All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin). concurrent chemoradiotherapy group radiotherapy All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
Trial Locations
- Locations (4)
Huai'an second peiple's Hospital
🇨🇳Huai'an, Jiangsu, China
Lianshui County Peoples Hospital
🇨🇳Huai'an, Jiangsu, China
xuyi peiple's Hospital
🇨🇳Xu Yi, Jiangsu, China
Chinese Peiple's Liberation Army No.82 Hospital
🇨🇳Huai'an, Jiangsu, China