A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 434
- Locations
- 4
- Primary Endpoint
- Disease-free survival (DFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
Arms & Interventions
concurrent chemoradiotherapy group
All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
Intervention: Docetaxel plus cisplatin (Drug)
concurrent chemoradiotherapy group
All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
Intervention: radiotherapy (Radiation)
radiotherapy group
All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week).
Intervention: radiotherapy (Radiation)
Outcomes
Primary Outcomes
Disease-free survival (DFS)
Time Frame: 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 Outcomes
- treatment-related toxicities(From the date of randomization until six months after treatment completion)
- Quality of life(QOL)(1 year)
- Overall survival (OS)(From date of randomization to death from any cause, assessed up to 3 years)