Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

March 16, 2023 updated by: The First Affiliated Hospital with Nanjing Medical University

A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy

This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Test grouping:

Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group;

Specific chemotherapy regimens:

Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.

Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life

Study Type

Interventional

Enrollment (Anticipated)

1216

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
  2. Esophageal squamous cell carcinoma proved by histopathology;
  3. Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
  4. According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
  5. ECOG 0-1; life expectancy > 6 months;
  6. No chemotherapy was used before selection;
  7. No history of radiotherapy;
  8. No surgical treatment;
  9. No serious allergic history;
  10. Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;

Exclusion Criteria:

  1. History of malignant tumors in other parts;
  2. Duplicate carcinoma of the esophagus;
  3. Pregnant or lactating patients;
  4. Fertility but not using contraceptive measures;
  5. Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
  6. During the active period of infectious diseases;
  7. Participate in other clinical trials at present or within four weeks before enrollment;
  8. Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
  9. After esophageal stent placement;
  10. Cases with perforation tendency;
  11. Have a history of organ transplantation.
  12. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
  13. Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

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
Sham Comparator: Group A: radical chemoradiotherapy group;
Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.
Combination product: Concurrent chemotherapy (2 courses)
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles;
Experimental: Group B: radical chemoradiotherapy combined with consolidation chemotherapy group
Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.
Combination product: Consolidation chemotherapy (4 courses)
Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-years overall survival (OS)
Time Frame: up to 3 years
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
up to 3 years
5-years overall survival (OS)
Time Frame: up to 5 years
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year progression-free survival (PFS)
Time Frame: up to 3 years
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
up to 3 years
Objective response rate (ORR) Objective response rate (ORR)
Time Frame: through study completion, an average of 36 month
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
through study completion, an average of 36 month
5-year progression-free survival (PFS)
Time Frame: up to 5 years
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
up to 5 years

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Xiaolin GE, MM, The First Affiliated Hospital with Nanjing Medical University

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)

June 30, 2021

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2028

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GXL-003

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.

Clinical Trials on Chemotherapy Effect

Clinical Trials on Concurrent chemotherapy (2 courses)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe