Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
Concurrent chemoradiotherapy, Cisplatin, postoperative head and neck squamous cell carcinoma
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).
Interventions
DRUGDrug：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
Sponsors
Hunan Cancer Hospital
Guilin Medical University, China
Jiangsu Cancer Institute & Hospital
Xiangya Hospital of Central South University
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactLei Chen, M.D
Outcome results
None listed