Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMing-Yuan Chen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 psychological, social, domestic or geological reasons.
During pregnancy or lactation.
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy
Procedure/Surgeryin experimental arm 1
Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection
Procedure/Surgeryin experimental arm 2
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Surgery plus low dose radiotherapyExperimental treatment 1 intervention
Group B: SurgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Local Regional Relapse-Free Survival (LRRFS)
The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
Time frame
2 yearsSecondary outcomes
1
The incidence of serious complications
Common Adverse Event Evaluation Criteria (CTCAE) version 5.0 evaluates acute and late-stage subjective toxicity reactions.
Time frame
2 years2
Overall Survival (OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Time frame
2 years3
Distant Metastasis-Free Survival (DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Time frame
2 years4
Progression-Free Survival (PFS)
The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ming-Yuan Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Fifth Affiliated Hospital of Guangzhou Medical University
Collaborator
Huazhong University of Science and Technology Union Shenzhen Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
First People's Hospital of Foshan
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Source ClinicalTrials.gov