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

Sun Yat-sen University

Status

Unknown

Conditions

Nasopharyngeal Carcinoma

Treatments

Radiation: medial group retropharyngeal node（MRLN） sparing

Study type

Interventional

Funder types

Other

Identifiers

NCT03346109

2017-FXY-114

Details and patient eligibility

About

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.

Full 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.

Enrollment

568 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.