pfront surgery followed by adjuvant treatment versus chemoradiotherapy (CCRT) in Head and Neck squamous cell carcinoma of unknown primary with neck node metastasis:A phase III randomized controlled trial. - SCCoUP Trial

TATA MEMORIAL HOSPITA0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Head Neck Cancer of Unknown Primary (HNCUP), as defined by AJCC 8th edition.
•2. Squamous cell carcinoma only.
•3. Karnofsky performance status >=70 and adequate hematologic, renal, and hepatic function.
•4. Patients consenting to participate in the study.

•1. Lymph node (core) biopsy positive patients for HPV (p16-IHC) and EBV (EBV-ISH) and
•2. Isolated Level IV metastasis in a case of HNCUP
•3. Prior chemotherapy or radiation therapy to the head and neck region.
•4. Evidence of distant metastasis.
•5. Prior malignancy within the previous 5 years, other than curatively treated skin cancer or cervical intraepithelial neoplasia.
•5. Pregnant and lactating women.
•6. Unresectable nodal disease
•7. Exclusion criteria for cisplatin, i.e.
•â?? The presence of moderate to severe sensorineural hearing loss.
•â?? The presence of renal dysfunction, i.e. creatinine clearance < 50 cc/min
•â?? The presence of inadequate bone marrow reserve, as defined as Hb < 9 g/dl, absolute neutrophil count < 1.5 x 109/L, platelet count < 100 x 109/L
•â?? The presence of hepatic dysfunction, i.e. bilirubin >= 2 x upper limit normal (ULN), AST/ALT/ALP >= 2.5 xULN, S. albumin < 30 g/L.
•8. Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections.

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