Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

NCT05775419 | Recruiting

• 1 other identifier: GXL-003
• Study Type: interventional
• Target: 1,216
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 3-year progression-free survival (PFS)

  up to 3 years

• Objective response rate (ORR) Objective response rate (ORR)

  through study completion, an average of 36 month

• 5-year progression-free survival (PFS)

  up to 5 years

Study Arms (2)

Group A: radical chemoradiotherapy group;

SHAM COMPARATOR

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)

Group B: radical chemoradiotherapy combined with consolidation chemotherapy group

EXPERIMENTAL

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)

Interventions

Consolidation chemotherapy (4 courses) COMBINATION_PRODUCT

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;

Group B: radical chemoradiotherapy combined with consolidation chemotherapy group

Concurrent chemotherapy (2 courses) COMBINATION_PRODUCT

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

Group A: radical chemoradiotherapy group;

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Consolidation Chemotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Xiaolin GE, MM

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Xiaolin GE, MM

CONTACT

13951818797; doctorsxl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: March 20, 2023
• Study Start: June 30, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

CN (1)