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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Docetaxel plus cisplatin

radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal neoplasma, adjuvant therapy, chemotherapy, radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Chinese Peiple's Liberation Army No.82 HospitalRecruiting
Huai'an second peiple's HospitalRecruiting
Lianshui County Peoples HospitalRecruiting
xuyi peiple's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

concurrent chemoradiotherapy group

radiotherapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Disease-free survival (DFS)

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 the date of randomization until the date of death

treatment-related toxicities

Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0

Quality of life(QOL)

Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months.

Full Information

NCT ID

NCT03600831

First Posted

July 3, 2018

Last Updated

April 5, 2021

Sponsor

Huai'an First People's Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03600831

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 20, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Huai'an First People's Hospital

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

esophageal neoplasma, adjuvant therapy, chemotherapy, radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

434 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

concurrent chemoradiotherapy group

Arm Type

Experimental

Arm Description

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

Arm Title

radiotherapy group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel plus cisplatin

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease-free survival (DFS)

Description

From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。

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

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

From the date of randomization until the date of death

Time Frame

From date of randomization to death from any cause, assessed up to 3 years

Title

treatment-related toxicities

Description

Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0

Time Frame

From the date of randomization until six months after treatment completion

Title

Quality of life(QOL)

Description

Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wei-guo zhu, MD

Phone

+8613511555000

jshazwg@126.com

Facility Information:

Facility Name

Chinese Peiple's Liberation Army No.82 Hospital

City

Huai'an

State/Province

Jiangsu

ZIP/Postal Code

223300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qian-wen Li, MD

Facility Name

Huai'an second peiple's Hospital

City

Huai'an

State/Province

Jiangsu

ZIP/Postal Code

223300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li-qing Zhou, Phd

Facility Name

Lianshui County Peoples Hospital

City

Huai'an

State/Province

Jiangsu

ZIP/Postal Code

223300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

juan pu, MD

Facility Name

xuyi peiple's Hospital

City

Xu Yi

State/Province

Jiangsu

ZIP/Postal Code

211700

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lian Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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