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

Sponsor

Huai'an First People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03600831

Collaborator

The Second People's Hospital of Huai'an (Other), lian shui county People's Hospital (Other), xuyi People's Hospital (Other), Chinese People's Liberation Army No. 82 Hospital (Other)

434

Enrollment

Locations

Arms

64.4

Anticipated Duration (Months)

108.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: Docetaxel plus cisplatin Radiation: radiotherapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

434 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 20, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: concurrent chemoradiotherapy group All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).	Drug: Docetaxel plus cisplatin 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)
Active Comparator: radiotherapy group All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week).	Radiation: radiotherapy radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)

Arm

Intervention/Treatment

Experimental: concurrent chemoradiotherapy group

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

Drug: Docetaxel plus cisplatin

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)

Active Comparator: radiotherapy group

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

Radiation: radiotherapy

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

Outcome Measures

Primary Outcome Measures

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

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese Peiple's Liberation Army No.82 Hospital	Huai'an	Jiangsu	China	223300
2	Huai'an second peiple's Hospital	Huai'an	Jiangsu	China	223300
3	Lianshui County Peoples Hospital	Huai'an	Jiangsu	China	223300
4	xuyi peiple's Hospital	Xu Yi	Jiangsu	China	211700