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

S

Shanghai Proton and Heavy Ion Center

Status and phase

Not yet enrolling
Phase 2

Conditions

Locally Recurrent Nasopharyngeal Carcinoma

Treatments

Radiation: Standardized CIRT
Radiation: Individualized CIRT

Study type

Interventional

Funder types

Other

Identifiers

NCT04533620
SPHIC-TR-HNCNS-2020-46

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Standardized CIRT
Active Comparator group
Description:
Patients will receive standardized CIRT with a dose of 63 GyE/21 fx.
Treatment:
Radiation: Standardized CIRT
Individualized CIRT
Experimental group
Description:
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.
Treatment:
Radiation: Individualized CIRT

Trial contacts and locations

1

Loading...

Central trial contact

Jiyi Hu, MD, PhD; Lin Kong, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems