Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

  • STATUS
    Recruiting
  • End date
    Dec 17, 2024
  • participants needed
    278
  • sponsor
    Sun Yat-sen University
Updated on 17 August 2021

Summary

This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.

Details
Condition Local Advanced High Risk Nasopharyngeal Carcinoma
Treatment IMRT combine with cisplatin concurrent chemotherapy, IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Clinical Study IdentifierNCT02973386
SponsorSun Yat-sen University
Last Modified on17 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
Clinical stage III~IVb(UICC/AJCC 7th)
Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 T3-4N2M0; 5 T1-4N3M0;6 EBV-DNA PCR quantitative>210E4 copy/l(pre-treatment)
No distant metastasis
Karnofsky Performance Status Scale70
WBC count 4109/Lneutrophil differential count 1.5109/L,Hemoglobin 90g/L platelet count 100109/L
ALT or AST 2.5ULN,bilirubin 2.5ULN,Serum creatinine 1.5ULN or Serum creatinine clearance60ml/min
Sign the informed consent

Exclusion Criteria

Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
Younger than 18 years old or older than 70 years old
Are receiving other drugs treanment
kidney disease
Have suffered from other tumor or now suffering from other tumor
Have recieved chemotherapy or radiotherapy
Pregnancy or lactation
unstable heart disease need timely treatment
Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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