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

NCT07125755 | Recruiting Phase 3 DMC

• 1 other identifier: SL-B2025-367-02
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 7

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

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Keywords

Concurrent chemoradiotherapy; Cisplatin; postoperative head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Failure-free survival (FFS)

  calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.

  3 years

Secondary Outcomes (4)

• Overall survival (OS)

  3 years

• Distant metastasis-free survival(DMFS)

  3 years

• locoregional recurrence-free survival (LRRFS)

  3 years

• Quality of life (QoL)

  3 years

Study Arms (2)

2 courses of cisplatin chemoradiotherapy arm

EXPERIMENTAL

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: Cisplatin

Postoperative adjuvant radiotherapy alone

NO INTERVENTION

Patients will receive intensity modulated radiotherapy (total dose: \> 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week)

Interventions

Cisplatin DRUG

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

2 courses of cisplatin chemoradiotherapy arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (7)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 523000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 523000, China

RECRUITING

Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

RECRUITING

Hainan General Hospital

Sanya, Hainan, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, China

RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Lei Chen Principal Investigator, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Chen, M.D

CONTACT

+862013570051477; chenlei@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 15, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2031
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)