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Recruiting NCT06688760

Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma

Trial Parameters

Condition Nasopharyngeal Carcinoma
Sponsor Ming-Yuan Chen
Study Type INTERVENTIONAL
Phase N/A
Enrollment 86
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-11-01
Completion 2028-11-01
Interventions
Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose RadiotherapyEndoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection

Brief Summary

The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma.

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria: * Performance Status Score 0-1 points. * Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically. * According to the UICC/AJCC eighth edition staging, the patient is defined as T1N0M0 stage I. * Adequate organ function: WBC ≥ 4×10\^9 /L, NEUT ≥ 2×10\^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10\^9/L, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min. * Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol. Exclusion Criteria: * Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy. * Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy. * Unable to cooperate with regular follow-up due to psycholo

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