Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
NCT ID: NCT07125755
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
386 participants
INTERVENTIONAL
2025-08-15
2031-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
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
Postoperative adjuvant radiotherapy alone
Patients will receive intensity modulated radiotherapy (total dose: \> 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week)
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Lei Chen
Clinical Professor
Principal Investigators
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Lei Chen Principal Investigator, M.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SL-B2025-367-02
Identifier Type: -
Identifier Source: org_study_id
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