Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Squamous Cell Cancer of Head and Neck (SCCHN)
• Interventions: Drug: Cisplatin

• Registration Number: NCT07125755
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-10
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study Start: 2025-08-15
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2028-08-15
• Study Completion: 2031-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

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

• Stages

B. Radical surgery has been performed, and there are intermediary-risk factors (pT3/pT4, pN2/pN3, positive lymph nodes in the cervical IV/V region of oral cancer, nerve invasion, and vascular invasion).

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 courses of cisplatin chemoradiotherapy arm	Cisplatin	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	3 years	calculated from enrolment to the date of death from any cause.
Distant metastasis-free survival(DMFS)	3 years	calculated from enrolment to the date of first distant metastasis.
locoregional recurrence-free survival (LRRFS)	3 years	calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence.
Quality of life (QoL)	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.

Trial Locations

Locations (6)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Affiliated Hospital of Guilin Medical College; 🇨🇳 Guilin, Guangxi, China

Hainan General Hospital; 🇨🇳 Sanya, Hainan, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China