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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 422
- Locations
- 5
- Primary Endpoint
- Failure-free survival (FFS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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) >
- •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.
Arms & Interventions
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).
Intervention: Drug：Cisplatin (Drug)
3 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, once every 3 weeks, 3 times in total, days 1, 22, and 43).
Intervention: Drug：Cisplatin (Drug)
Outcomes
Primary Outcomes
Failure-free survival (FFS)
Time Frame: 3 years
calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.
Secondary Outcomes
- Quality of life (QoL)(3 years)
- Overall survival (OS)(3 years)
- Distant metastasis-free survival(DMFS)(3 years)
- locoregional recurrence-free survival (LRRFS)(3 years)
Investigators
Lei Chen
Clinical Professor
Sun Yat-sen University