Clinical trial NCT06492460: 2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Concurrent chemoradiotherapy
Cisplatin
postoperative head and neck squamous cell carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Hunan Cancer Hospital
name: Guilin Medical University, China
name: Jiangsu Cancer Institute & Hospital
name: Xiangya Hospital of Central South University
First posted: 2024-07-09
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Failure-free survival (FFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Distant metastasis-free survival(DMFS)
timeFrame: 3 years
measure: locoregional recurrence-free survival (LRRFS)
timeFrame: 3 years
measure: Quality of life (QoL)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical College
state: Guangxi
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Sun Yat-sen University
name: Lei Chen, M.D
role: PRINCIPAL_INVESTIGATOR
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