Clinical trial NCT04533620: Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma
Official title: Predictive-Model Based Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: A Phase 2 Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Locally Recurrent Nasopharyngeal Carcinoma
Keywords: Locally recurrent nasopharyngeal carcinoma
Individualized carbon-ion radiotherapy
Predictive model of mucosal necrosis
Survival
Toxicity
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: From randomization to death or disease progression, a median of 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: From randomization to death, a median of 2 years
measure: Local progression-free survival
timeFrame: From randomization to local failure, a median of 2 years
measure: Regional progression-free survival
timeFrame: From randomization to regional failure, a median of 2 years
measure: Distant metastasis-free survival
timeFrame: From randomization to distant metastasis, a median of 2 years
measure: Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0
timeFrame: Within 3 months after initiation of radiation therapy
measure: Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0
timeFrame: Three months after initiation of radiation therapy
measure: Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire.
timeFrame: Throughout the study, an average of 2 years
measure: Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire.
timeFrame: Throughout the study, an average of 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: Jiade J Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: