Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

STATUS

Recruiting
participants needed

129
sponsor

Fujian Cancer Hospital

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Updated on 19 February 2024

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nasopharyngeal carcinoma

chemoradiotherapy

carcinoma

capecitabine

alt/ast

nasopharyngeal biopsy

Summary

This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in patients with N3.

Details

Condition	Carcinoma, Nasopharyngeal Cancer, Nasopharyngeal Cancer
Age	18years - 65years
Treatment	Capecitabine/Tiggio
Clinical Study Identifier	NCT04220528
Sponsor	Fujian Cancer Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma
	No distant metastatic stage N3 nasopharyngeal carcinoma was first diagnosed (according to the 8th edition UICC/AJCC nasopharyngeal carcinoma staging system defined as any T and N3M0 stage nasopharyngeal carcinoma)
	Aged 18-65
	At least one measurable tumor lesion
	PS (ECOG standard) 0-1
	Adequate hematopoietic function: WBC3.5109/L, Hb100g/L, PLT100109/L
	Normal liver and kidney functions: ALT/AST < 2.5 times the upper limit of normal value (ULN), total bilirubin < 1.5ULN;Serum creatinine < 1.5ULN
	Expected survival period 6 months
	Signing informed consent
	Follow up regularly and comply with test requirements
Exclusion Criteria
	Patients with distant organ metastasis
	Recurrent nasopharyngeal carcinoma
	Creatinine clearance rate <60ml/ min
	Have received chemotherapy, radiotherapy or targeted therapy
	Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer)
	Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc
	Active systemic infection
	History of serious lung or heart disease
	Drug or alcohol abuse
	No or limited capacity for civil conduct
	The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study
	Receive chronic systemic immunotherapy or hormone therapy outside the study
	Pregnancy or lactation period
	Patients receive blind treatment in other clinical studies

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Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC