Locally Recurrent Nasopharyngeal Carcinoma
Conditions
Keywords
Locally recurrent nasopharyngeal carcinoma, Individualized carbon-ion radiotherapy, Predictive model of mucosal necrosis, Survival, Toxicity
Brief summary
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups.
Detailed description
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized CIRT with a dose of 63 gray equivalent (GyE) in 21 fractions (fx). This regimen was obtained from our previous phase 1 (dose escalation) study. For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups. The secondary endpoints include 2-year overall survival (OS), local progression-free survival, regional progression-free survival, distant metastasis-free survival, toxicities and quality of life.
Interventions
RADIATIONStandardized CIRT
CIRT with a dose of 63 GyE/21 fx
RADIATIONIndividualized CIRT
A predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively.
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 17-70 years. * Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma. * Failed previous definitive radiotherapy at least 6 months ago. * Only had 1 previous course of radiotherapy. * Eastern Cooperative Oncology Group score: 0-1. * Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \< 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase \< 1.5 upper limit of normal; 5) SCr \< 1.5mg/dl; creatinine clearance rate \> 60ml/min. * Willing to accept adequate contraception for women with childbearing potential. * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.
Exclusion criteria
* Presence of distant metastasis. * Without measurable lesion. * Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. * Accompanied with severe major organ dysfunction. * Presence of mental disease that may influence the understanding of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | From randomization to death or disease progression, a median of 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Local progression-free survival | From randomization to local failure, a median of 2 years |
| Regional progression-free survival | From randomization to regional failure, a median of 2 years |
| Distant metastasis-free survival | From randomization to distant metastasis, a median of 2 years |
| Overall survival | From randomization to death, a median of 2 years |
| Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0 | Three months after initiation of radiation therapy |
| Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire. | Throughout the study, an average of 2 years |
| Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire. | Throughout the study, an average of 2 years |
| Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0 | Within 3 months after initiation of radiation therapy |
Countries
China
Contacts
Primary ContactLin Kong, MD
Backup ContactJiyi Hu, MD, PhD
Outcome results
None listed