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Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Primary Purpose

Thoracic Esophageal Squamous Cell Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

chemotherapy

About this trial

This is an interventional treatment trial for Thoracic Esophageal Squamous Cell Carcinoma focused on measuring adjuvant chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery.
T≥3 or N≥1, and more than 15 lymph nodes were dissected.
Age ≥18 years and ≤75 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Adequate hematological function:
absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL.
Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN.
Adequate renal function:
serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min.
Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent

Exclusion Criteria:

Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study.
Serious postoperative complications that will affect progress of chemotherapy.
Patients with chemotherapy contraindications.
Women who are pregnant or breast-feeding or who are planning for pregnancy.
Unable to complete the follow-up as planned.
Without informed consent due to psychological, family, social and other factors.

Sites / Locations

Sun Yat-sen Uniersity Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

control group

Arm Description

patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles

patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery.

Outcomes

Primary Outcome Measures

Disease-free survival

Patients were images with computed tomography (CT) scan

Secondary Outcome Measures

overall survival

Patients were images with computed tomography (CT) scan

Full Information

NCT ID

NCT04174079

First Posted

November 19, 2019

Last Updated

September 26, 2023

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04174079

Brief Title

Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Official Title

A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 11, 2019 (Actual)

Primary Completion Date

May 2029 (Anticipated)

Study Completion Date

May 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group

Detailed Description

Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.

6. Conditions and Keywords

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

Thoracic Esophageal Squamous Cell Carcinoma

Keywords

adjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

control group

Arm Type

No Intervention

Arm Description

patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery.

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Intervention Description

Primary Outcome Measure Information:

Title

Disease-free survival

Description

Patients were images with computed tomography (CT) scan

Time Frame

At most 5 years after enrollment

Secondary Outcome Measure Information:

Title

overall survival

Description

Patients were images with computed tomography (CT) scan

Time Frame

At most 5 years after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery. T≥3 or N≥1, and more than 15 lymph nodes were dissected. Age ≥18 years and ≤75 years. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL. Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN. Adequate renal function: serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min. Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent Exclusion Criteria: Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study. Serious postoperative complications that will affect progress of chemotherapy. Patients with chemotherapy contraindications. Women who are pregnant or breast-feeding or who are planning for pregnancy. Unable to complete the follow-up as planned. Without informed consent due to psychological, family, social and other factors.

Central Contact Person:

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

Peng Lin, professor

Phone

+86-20-87343314

linpeng@sysucc.org.cn

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

Xing Ru Ping

Phone

+86-20-87343736

xingrp@sysucc.org.cn

Facility Information:

Facility Name

Sun Yat-sen Uniersity Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peng Lin, professor

Phone

+86-20-87343314

linpeng@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Xing Ru Ping

Phone

+86-20-87343736

xingrp@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

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