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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03346109
• Other study ID #: 2017-FXY-114
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 568
• Est. completion date: December 30, 2022
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• medial group retropharyngeal node(MRLN) sparing
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local replase-free survival rate	Local failure-free survival is calculated from randomization to the first local failure	3 Year
Secondary	Incidence of acute and late toxicity	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 year
Secondary	Incidence of out-field recurrence rate	Number of participants with out-field recurrence	3 Year
Secondary	Dysphagia related quality of life	Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35	1 year
Secondary	Overall survival	Overall survival is calculated from randomization to death from any cause	3 Year