Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06492460

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

Led by Sun Yat-sen University · Updated on 2025-08-14

422

Participants Needed

5

Research Sites

460 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

H

Hunan Cancer Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with head and neck squamous cell carcinoma, stages III or IV
  • Have undergone radical surgery with high-risk factors such as extracapsular invasion of cervical lymph nodes or positive/inadequate incisional margins
  • No evidence of distant metastasis (M0)
  • Karnofsky performance status greater than 70
  • Normal bone marrow function with white blood cell count over 4 x 10^9/L, hemoglobin over 120 g/L (males) or 110 g/L (females), and platelet count over 100 x 10^9/L
  • Normal liver function with ALT and AST less than 1.5 times upper limit, ALP less than 2.5 times upper limit, and bilirubin below upper limit
  • Normal kidney function with creatinine clearance over 60 ml/min
  • Able to understand the study and sign informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 or over 70 years
  • Receiving palliative treatment
  • Previous chemotherapy except induction chemotherapy before surgery
  • Previous radiation therapy
  • Women who are pregnant or breastfeeding
  • History of other malignant tumors
  • Serious medical conditions that increase risk or affect study compliance, including unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, or mental illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

Not Yet Recruiting

3

Hunan Cancer Hospital

Changsha, Hunan, China

Not Yet Recruiting

4

Xiangya Hospital, Central South University

Changsha, Hunan, China

Not Yet Recruiting

5

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Not Yet Recruiting

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Research Team

L

Lei Chen, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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