Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cisplatin.
- Who it may be relevant to
- Registry conditions: Squamous Cell Cancer of Head and Neck (SCCHN). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multicenter, Randomized Controlled Phase 3 Clinical Trial Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
Overview
The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
Interventions
- 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
Primary outcome measures
- Failure-free survival (FFS) [Time frame: 3 years]
Secondary outcome measures (4)
- Overall survival (OS) [Time frame: 3 years]
- Distant metastasis-free survival(DMFS) [Time frame: 3 years]
- locoregional recurrence-free survival (LRRFS) [Time frame: 3 years]
- Quality of life (QoL) [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 7 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou
- Affiliated Hospital of Guilin Medical College — Guilin
- Hainan General Hospital — Sanya
- Hunan Cancer Hospital — Changsha
- Xiangya Hospital, Central South University — Changsha
- Jiangsu Cancer Hospital — Nanjing
Identifiers
NCT: NCT07125755 · SL-B2025-367-02