Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huai'an First People's Hospital
• Collaborators: Chinese People's Liberation Army No. 82 Hospital; Huai'an Second People's Hospital; lian shui county People's Hospital; xuyi People's Hospital
• Treatments: Cisplatin; Docetaxel

Criteria

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;