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Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

Primary Purpose

Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Consolidation chemotherapy (4 courses)
Concurrent chemotherapy (2 courses)
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria: Age 18-70 years old, not limited to male or female; at least able to take liquid diet; Esophageal squamous cell carcinoma proved by histopathology; Esophageal squamous cell carcinoma that is inoperable or refuses surgery, According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage; ECOG 0-1; life expectancy > 6 months; No chemotherapy was used before selection; No history of radiotherapy; No surgical treatment; No serious allergic history; 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: History of malignant tumors in other parts; Duplicate carcinoma of the esophagus; Pregnant or lactating patients; Fertility but not using contraceptive measures; Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes; During the active period of infectious diseases; Participate in other clinical trials at present or within four weeks before enrollment; Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine); After esophageal stent placement; Cases with perforation tendency; Have a history of organ transplantation. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases; 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.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Group A: radical chemoradiotherapy group;

Group B: radical chemoradiotherapy combined with consolidation chemotherapy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

3-year progression-free survival (PFS)
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
Objective response rate (ORR) Objective response rate (ORR)
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
5-year progression-free survival (PFS)
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.

Full Information

First Posted
September 7, 2022
Last Updated
March 16, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05775419
Brief Title
Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: radical chemoradiotherapy group;
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Group B: radical chemoradiotherapy combined with consolidation chemotherapy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Consolidation chemotherapy (4 courses)
Intervention Description
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;
Intervention Type
Combination Product
Intervention Name(s)
Concurrent chemotherapy (2 courses)
Intervention Description
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles;
Primary Outcome Measure Information:
Title
3-years overall survival (OS)
Description
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
Time Frame
up to 3 years
Title
5-years overall survival (OS)
Description
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
3-year progression-free survival (PFS)
Description
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
Time Frame
up to 3 years
Title
Objective response rate (ORR) Objective response rate (ORR)
Description
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Time Frame
through study completion, an average of 36 month
Title
5-year progression-free survival (PFS)
Description
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years old, not limited to male or female; at least able to take liquid diet; Esophageal squamous cell carcinoma proved by histopathology; Esophageal squamous cell carcinoma that is inoperable or refuses surgery, According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage; ECOG 0-1; life expectancy > 6 months; No chemotherapy was used before selection; No history of radiotherapy; No surgical treatment; No serious allergic history; 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: History of malignant tumors in other parts; Duplicate carcinoma of the esophagus; Pregnant or lactating patients; Fertility but not using contraceptive measures; Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes; During the active period of infectious diseases; Participate in other clinical trials at present or within four weeks before enrollment; Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine); After esophageal stent placement; Cases with perforation tendency; Have a history of organ transplantation. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolin GE, MM
Phone
13951818797
Email
doctorsxl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolin GE, MM
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolin Ge, PhD
Phone
13951818797
Email
doctorsxl@163.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

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