Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775419
• Other study ID #: GXL-003
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: June 30, 2028

Study information

• Verified date: March 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xiaolin GE, MM
• Phone: 13951818797
• Email: doctorsxl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1216
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Chemotherapy Effect
• Drug-Related Side Effects and Adverse Reactions
• Esophageal Squamous Cell Carcinoma
• Side Effect of Drug

Intervention

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;
• Concurrent chemotherapy (2 courses)
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles;

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-years overall survival (OS)	Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.	up to 3 years
Primary	5-years overall survival (OS)	Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.	up to 5 years
Secondary	3-year progression-free survival (PFS)	The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.	up to 3 years
Secondary	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	through study completion, an average of 36 month
Secondary	5-year progression-free survival (PFS)	The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.	up to 5 years