Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, medial group retropharyngeal node
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.
Interventions
RADIATIONmedial 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local replase-free survival rate | 3 Year | Local failure-free survival is calculated from randomization to the first local failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute and late toxicity | 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Incidence of out-field recurrence rate | 3 Year | Number of participants with out-field recurrence |
| Dysphagia related quality of life | 1 year | Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35 |
| Overall survival | 3 Year | Overall survival is calculated from randomization to death from any cause |
Countries
China
Outcome results
None listed