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

January 6, 2024 updated by: Huai'an First People's Hospital

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

434

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Chinese Peiple's Liberation Army No.82 Hospital
      • Huai'an, Jiangsu, China, 223300
        • Huai'an second peiple's Hospital
      • Huai'an, Jiangsu, China, 223300
        • Lianshui County Peoples Hospital
      • Xu Yi, Jiangsu, China, 211700
        • xuyi peiple's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. biopsy-confirmed esophageal squamous cell carcinoma
  2. age ≤ 70 years old,
  3. Karnofsky performance status ≥ 70,
  4. R0 esophagectomy according to the pathological examination of the resected specimens,
  5. postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
  6. 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;.
  7. no previous treatment or severe complications
  8. Written informed consent

Exclusion Criteria:

  1. previous treatment with chemotherapy or radiotherapy
  2. greater than 3 months after surgery
  3. complete esophageal obstruction after surgery, esophageal perforation;
  4. other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
  5. pregnant or breast-feeding women;
  6. patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease;
  7. drug addiction, Alcoholism or AIDS;
  8. uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  9. with clear chemotherapy drug allergy
  10. participation in other interventional clinical trials within 30 days;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: concurrent chemoradiotherapy group
All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks
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).
radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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。
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 Measures

Outcome Measure
Measure Description
Time Frame
treatment-related toxicities
Time Frame: 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
From the date of randomization until six months after treatment completion
Overall survival (OS)
Time Frame: From date of randomization to death from any cause, assessed up to 3 years
From the date of randomization until the date of death
From date of randomization to death from any cause, assessed up to 3 years
Quality of life(QOL)
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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