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

August 10, 2025 updated by: Lei Chen, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of the trial was to evaluate whether the 3-year failure-free survival (FFS) rate in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant radiotherapy and 2 courses of concurrent cisplatin chemotherapy after surgery was no less than 10% compared with 3 courses of concurrent cisplatin chemotherapy. The secondary objective was to evaluate efficacy and toxicity of 2 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1 and 22) during adjuvant intensity-modulated radiation therapy will be compared with 3 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1, 22 and 43).

Study Type

Interventional

Enrollment (Estimated)

422

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China
        • Not yet recruiting
        • Affiliated Hospital of Guilin Medical College
        • Contact:
          • Wei Jiang, M.D
          • Phone Number: +8677313788561863
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Bei Yang, M.D
          • Phone Number: +8673113507403512
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital, Central South University
        • Contact:
          • Haijun Wu, M.D
          • Phone Number: +8673113975110101
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Lirong Wu, M.D
          • Phone Number: +862513701588737

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A. The pathological type is head and neck squamous cell carcinoma

  • Stages III and IV

B. Radical surgery has been performed with high risk factors (one of below)

  • extracapsular invasion of cervical metastatic lymph nodes
  • positive incisional margin or inadequate incisional margin safety distance

C. No evidence of distant metastasis (M0).

D. Functional status: Karnofsky scale (KPS) > 70.

E. Normal bone marrow function:

  • white blood cell count > 4×109/L
  • hemoglobin > 120g/L in males, 110g/L in females
  • platelet count > 100×109/L

G. Normal liver function:

  • alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 1.5 times the upper limit of normal (ULN)
  • alkaline phosphatase (ALP) < 2.5×ULN
  • bilirubin < ULN.

H. Normal renal function: creatinine clearance > 60 ml/min.

I. Patients must be informed of the basic contents of this study and sign informed consent.

Exclusion Criteria:

A. Age >70 years or <18 years.

B. Treatment is palliative.

C. Previous chemotherapy (except induction chemotherapy prior to surgery).

D. Previous radiation therapy.

E. Women who are pregnant or breastfeeding

F. Previous history of malignant tumor.

G. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:

  • unstable heart disease that requires treatment
  • kidney disease
  • chronic hepatitis
  • poorly controlled diabetes (fasting blood glucose > 1.5×ULN)
  • mental illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 courses of cisplatin chemoradiotherapy arm
Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22).
Drug: Drug：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
Other Names:
  • CDDP Drug
Experimental: 3 courses of cisplatin chemoradiotherapy arm
Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, once every 3 weeks, 3 times in total, days 1, 22, and 43).
Drug: Drug：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
Other Names:
  • CDDP Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure-free survival (FFS)
Time Frame: 3 years
calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 3 years
calculated from enrolment to the date of death from any cause.
3 years
Distant metastasis-free survival(DMFS)
Time Frame: 3 years
calculated from enrolment to the date of first distant metastasis.
3 years
locoregional recurrence-free survival (LRRFS)
Time Frame: 3 years
calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence.
3 years
Quality of life (QoL)
Time Frame: 3 years
The change of QoL from randomization to the start of radiotherapy,the end of radiotherapy,13-16 weeks after radiotherapy,2 years and 3 years after randomization. The EORTC QoL questionnaire-C30(EORTC quality of life questionnaire-C30#version 3.0 will be used. This questionnaire comprises 30 questions,24 of which are aggregated into nine multi- question scales,that is,five functioning scales (e.g.,physical),three symptom scales (e.g.,fatigue)and one global health status scale. The remaining six single-question (e.g.,dyspnoea)scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Guilin Medical University, China
Xiangya Hospital of Central South University
Hunan Cancer Hospital
Jiangsu Cancer Institute & Hospital

Investigators

  • Principal Investigator: Lei Chen, M.D, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

September 20, 2029

Study Completion (Estimated)

July 17, 2033

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 10, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-B2024-323-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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