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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
medial group retropharyngeal node（MRLN） sparing
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, medial group retropharyngeal node

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MRLN sparing group

MRLN prophylactic irradiation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 15, 2017
Last Updated
April 4, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03346109
Brief Title
To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
Official Title
Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, medial group retropharyngeal node

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRLN sparing group
Arm Type
Experimental
Arm Description
Patients in medial group retropharyngeal node（MRLN） sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr
Arm Title
MRLN prophylactic irradiation group
Arm Type
No Intervention
Arm Description
Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr
Intervention Type
Radiation
Intervention Name(s)
medial group retropharyngeal node（MRLN） sparing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local replase-free survival rate
Description
Local failure-free survival is calculated from randomization to the first local failure
Time Frame
3 Year
Secondary Outcome Measure Information:
Title
Incidence of acute and late toxicity
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
1 year
Title
Incidence of out-field recurrence rate
Description
Number of participants with out-field recurrence
Time Frame
3 Year
Title
Dysphagia related quality of life
Description
Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35
Time Frame
1 year
Title
Overall survival
Description
Overall survival is calculated from randomization to death from any cause
Time Frame
3 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ma, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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