Trial | NCT03600831  Report issue

Title

Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    434
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 Started
Aug 20
2018
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Apr 06
2021

Drug Docetaxel plus cisplatin [docetaxel (taxotere), cisplatin (platinol)]

cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks

Radiation radiotherapy

radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)

concurrent chemoradiotherapy group Experimental

All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).

radiotherapy group Active Comparator

All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week).

Criteria 

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;
No Results Posted