NCT03346109

Brief Summary

This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
568

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

4.1 years

First QC Date

November 15, 2017

Last Update Submit

April 4, 2022

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinomamedial group retropharyngeal node

Outcome Measures

Primary Outcomes (1)

  • Local replase-free survival rate

    Local failure-free survival is calculated from randomization to the first local failure

    3 Year

Secondary Outcomes (4)

  • Incidence of acute and late toxicity

    1 year

  • Incidence of out-field recurrence rate

    3 Year

  • Dysphagia related quality of life

    1 year

  • Overall survival

    3 Year

Study Arms (2)

MRLN sparing group

EXPERIMENTAL

Patients in medial group retropharyngeal node（MRLN） sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr

Radiation: medial group retropharyngeal node（MRLN） sparing

MRLN prophylactic irradiation group

NO INTERVENTION

Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr

Interventions

medial group retropharyngeal node（MRLN） sparingRADIATION

Patients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr.

MRLN sparing group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients without medial group retropharyngeal node metastasis;
  • Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
  • Tumor staged as T1-4N0-3(according to the 8th AJCC edition);
  • No evidence of distant metastasis (M0);
  • Satisfactory performance status: Karnofsky scale (KPS) ≥ 70;
  • Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

  • Patients with medial group retropharyngeal node metastasis;
  • Aged \> 65 or \< 18;
  • Treatment with palliative intent;
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
  • Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
  • With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume);
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes;
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.

    PMID: 36746459DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jun Ma, M.D.

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 17, 2017

Study Start

November 16, 2017

Primary Completion

December 5, 2021

Study Completion

December 30, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Locations

CN(1)