RecruitingPhase 3NCT06492460

2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma

A Multicenter, Randomized Controlled, Non-inferior Phase 3 Clinical Trial of 2 Courses of Concurrent Cisplatin Chemoradiotherapy Versus 3 Courses After Surgery for High-risk Head and Neck Squamous Cell Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

422 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of this trial was to determine the value of 2 courses of cisplatin concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving only 2 cycles of cisplatin chemotherapy alongside radiation therapy (instead of the more common 3 cycles) after surgery is an effective and less toxic option for people with high-risk head and neck squamous cell carcinoma. High-risk means the cancer had spread to lymph nodes beyond the capsule, or the surgical margins were not clear. **You may be eligible if...** - You have had surgery for stage III or IV head and neck squamous cell carcinoma - Your pathology showed high-risk features (cancer beyond lymph node capsule or positive/close surgical margins) - Your cancer has not spread to distant parts of the body - Your general health and blood counts are adequate (Karnofsky score above 70) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastasis) - You have severe kidney, liver, or bone marrow dysfunction - You have already received prior radiation to the head and neck - You are pregnant 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

DRUGDrug:Cisplatin

Concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy


Locations(5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT06492460


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