2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- Drug: Drug：Cisplatin
- Registration Number
- NCT06492460
- Lead Sponsor
- Sun Yat-sen University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 422
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.
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 3 courses of cisplatin chemoradiotherapy arm Drug：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, once every 3 weeks, 3 times in total, days 1, 22, and 43). 2 courses of cisplatin chemoradiotherapy arm Drug：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 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.
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.
Trial Locations
- Locations (5)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical College
🇨🇳Guilin, Guangxi, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China