RecruitingNot ApplicableNCT05775419

Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

1,216 participants

Start Date

Jun 30, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing standard chemoradiotherapy (radiation plus chemotherapy) against chemoradiotherapy followed by additional consolidation chemotherapy in people with esophageal squamous cell carcinoma who either cannot or choose not to have surgery. Researchers want to know if adding more chemotherapy after radiation improves outcomes. **You may be eligible if...** - You are between 18 and 70 years old with confirmed esophageal squamous cell carcinoma - Your cancer is inoperable or you have declined surgery - You have not had prior chemotherapy, radiation, or surgery for this cancer - You have adequate blood counts and organ function - You are able to at least consume liquids **You may NOT be eligible if...** - You have received prior treatment (chemotherapy, radiation, or surgery) for this cancer - You have serious allergies or infections - You have poor organ function (kidney, liver, heart, or blood counts below thresholds) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTConsolidation 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;

COMBINATION_PRODUCTConcurrent chemotherapy (2 courses)

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


Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05775419


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