- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03346109
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
Conditions
Intervention / Treatment
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
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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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:
- 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.
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
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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
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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1 year
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Incidence of out-field recurrence rate
Time Frame: 3 Year
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Number of participants with out-field recurrence
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3 Year
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Dysphagia related quality of life
Time Frame: 1 year
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Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35
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1 year
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Overall survival
Time Frame: 3 Year
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Overall survival is calculated from randomization to death from any cause
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3 Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- 2017-FXY-114
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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