To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

April 4, 2022 updated by: Jun Ma, MD, Sun Yat-sen University

Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

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.

Study Overview

Status

Active, not recruiting

Detailed Description

In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population include only patients who receive their randomly assigned treatment.

Study Type

Interventional

Enrollment (Actual)

568

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRLN sparing group
Patients in medial group retropharyngeal node(MRLN) sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr
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.
No Intervention: MRLN prophylactic irradiation group
Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local replase-free survival rate
Time Frame: 3 Year
Local failure-free survival is calculated from randomization to the first local failure
3 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute and late toxicity
Time Frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 year
Incidence of out-field recurrence rate
Time Frame: 3 Year
Number of participants with out-field recurrence
3 Year
Dysphagia related quality of life
Time Frame: 1 year
Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35
1 year
Overall survival
Time Frame: 3 Year
Overall survival is calculated from randomization to death from any cause
3 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2017

Primary Completion (Actual)

December 5, 2021

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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