Head and Neck Squamous Carcinoma Clinical Trial
Official title:
Prospective, Multicentric, Randomized Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
This study was designed as a prospective, multicenter and randomized clinical study of radiotherapy combined with Nedaplatin contrast and cisplatin for local advanced head and neck squamous SCC, aiming to explore the efficacy, safety and long-term efficacy of this trial and control groups and provide some evidence for the selection of clinical treatment options.
Status | Not yet recruiting |
Enrollment | 164 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. voluntarily participated and signed the informed consent form in writing 2. is 18-70 and gender unlimited 3. histologically proved to be squamous cell carcinoma 4. as AJCC(version 8): -A, ?B head and neck squamous carcinoma unable or denied surgery; ~ A, ?B squamous carcinoma of the head and neck with the following postoperative risk factors: positive or proximal resection, lymph node envelope invasion, nerve and vascular invasion, primary focal pT3 or T4, N2 or N3 lymph node lesions. 5. card score = 70 6. survival is expected to be = for 6 months 7. fertility women should guarantee contraception during entering the study 8. Hemoglobin (HGB) = 100 g/L, leukocyte (WBC) = 3.5 × 10^9 / L*(unit normal), Platelet (PLT) = 100 × 10^9 / L(unit normal), neutrophil (WBC) = 1.5 × 10^9 / L*(unit normal) 9. liver function: 2.5 times of the upper normal limit (ULN), gluten transaminase (ASAT) <; total bilirubin <1.5 × ULN 10. renal function: Serum creatinine <ULN, endogenous creatinine clearance (Ccr) = 55 ml/min 11. has no severe complications such as hypertension, diabetes, coronary heart disease, and psychiatric history 12. (no history of head and neck radiotherapy or chemotherapy within 3 months) Exclusion Criteria: 1. has a distant transfer 2. has received epidermal growth factor targeted or immunotherapy 3. has developed other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ) 4. pregnant women or lactating women and women of childbearing age who refuse contraception during the treatment observation period 5. has a serious history of severe allergies or abnormalities 6. refused or cannot sign an informed consent to participate in the trial 7. substance abuse or alcohol addicts |
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Cancer Hospital of Guizhou Medical University | Guiyang | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Guiyang Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NCI CTCAE 5.0 | Acute virulence side response | 1 year | |
Primary | RESIST1.1 | Use to assess recent efficacy | 1year | |
Secondary | overall survival | Overall survival was assessed at 5 years after the end of chemoradiotherapy during the same period | 5 years | |
Secondary | Progression-free survival rate | Progression-free survival rate was assessed at 5 years after the end of chemoradiotherapy | 5 years |
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