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

Huai'an First People's Hospital4 sites in 1 country434 target enrollmentAugust 20, 2018

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsDocetaxel plus cisplatin radiotherapy

DrugsDocetaxel plus cisplatin

Overview

Phase: Phase 2
Intervention: Docetaxel plus cisplatin
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Huai'an First People's Hospital
Enrollment: 434
Locations: 4
Primary Endpoint: Disease-free survival (DFS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 20, 2018

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huai'an First People's Hospital

Responsible Party

Sponsor

Eligibility 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;

Arms & Interventions

concurrent chemoradiotherapy group

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

Intervention: Docetaxel plus cisplatin

concurrent chemoradiotherapy group

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

Intervention: radiotherapy

radiotherapy group

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

Intervention: radiotherapy

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)