Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma
- Conditions
- Locally Recurrent Nasopharyngeal Carcinoma
- Interventions
- Radiation: Individualized CIRTRadiation: Standardized CIRT
- Registration Number
- NCT04533620
- Lead Sponsor
- Shanghai Proton and Heavy Ion Center
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized CIRT Individualized CIRT A previously 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. Standardized CIRT Standardized CIRT Patients will receive standardized CIRT with a dose of 63 GyE/21 fx.
- Primary Outcome Measures
Name Time Method Progression-free survival From randomization to death or disease progression, a median of 2 years
- Secondary Outcome Measures
Name Time Method Distant metastasis-free survival From randomization to distant metastasis, a median of 2 years Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire. Throughout the study, an average of 2 years Regional progression-free survival From randomization to regional failure, 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 Overall survival From randomization to death, a median of 2 years Local progression-free survival From randomization to local failure, a median of 2 years Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0 Within 3 months after initiation of radiation therapy
Trial Locations
- Locations (1)
Shanghai Proton and Heavy Ion Center
🇨🇳Shanghai, Shanghai, China