Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma

Shanghai Proton and Heavy Ion Center96 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Standardized CIRTRADIATION

CIRT with a dose of 63 GyE/21 fx

Individualized CIRTRADIATION

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Progression-free survival

Time frame: From randomization to death or disease progression, a median of 2 years

Secondary Outcomes

Overall survival

Time frame: From randomization to death, a median of 2 years

Local progression-free survival

Time frame: From randomization to local failure, a median of 2 years

Regional progression-free survival

Time frame: From randomization to regional failure, a median of 2 years

Distant metastasis-free survival

Time frame: From randomization to distant metastasis, a median of 2 years

Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0

Time frame: Within 3 months after initiation of radiation therapy

Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0

Time frame: Three months after initiation of radiation therapy

Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire.

Time frame: Throughout the study, an average of 2 years

Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire.