Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma

Launched by GUIYANG MEDICAL UNIVERSITY · Sep 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced head and neck squamous carcinoma, a type of cancer that affects the cells lining the head and neck. The researchers want to see how effective and safe a combination of radiotherapy and two chemotherapy drugs, Nedaplatin and Cisplatin, can be for patients who cannot undergo surgery or have specific risk factors after surgery. This study aims to gather important information that could help doctors decide on the best treatment options for these patients.

To be eligible for this trial, participants need to be between 18 and 70 years old, have been diagnosed with squamous cell carcinoma of the head and neck, and have certain health conditions that make them suitable for the study. They should also be able to commit to the study, which includes signing a consent form and meeting specific health criteria. If someone decides to participate, they can expect careful monitoring and support throughout the trial. It's important to note that the trial is not yet recruiting participants, so there will be more information available soon for those interested in taking part.

Gender

ALL

Eligibility criteria

• 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, ⅣB head and neck squamous carcinoma unable or denied surgery; \~ A, ⅣB 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