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

Primary Purpose

Locally Recurrent Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Standardized CIRT
Individualized CIRT
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Recurrent Nasopharyngeal Carcinoma focused on measuring Locally recurrent nasopharyngeal carcinoma, Individualized carbon-ion radiotherapy, Predictive model of mucosal necrosis, Survival, Toxicity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Proton and Heavy Ion Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standardized CIRT

Individualized CIRT

Arm Description

Patients will receive standardized CIRT with a dose of 63 GyE/21 fx.

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.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Local progression-free survival
Regional progression-free survival
Distant metastasis-free survival
Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0
Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0
Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire.
Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire.

Full Information

First Posted
August 24, 2020
Last Updated
October 16, 2020
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT04533620
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Recurrent Nasopharyngeal Carcinoma
Keywords
Locally recurrent nasopharyngeal carcinoma, Individualized carbon-ion radiotherapy, Predictive model of mucosal necrosis, Survival, Toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standardized CIRT
Arm Type
Active Comparator
Arm Description
Patients will receive standardized CIRT with a dose of 63 GyE/21 fx.
Arm Title
Individualized CIRT
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Standardized CIRT
Intervention Description
CIRT with a dose of 63 GyE/21 fx
Intervention Type
Radiation
Intervention Name(s)
Individualized CIRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
From randomization to death or disease progression, a median of 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
From randomization to death, a median of 2 years
Title
Local progression-free survival
Time Frame
From randomization to local failure, a median of 2 years
Title
Regional progression-free survival
Time Frame
From randomization to regional failure, a median of 2 years
Title
Distant metastasis-free survival
Time Frame
From randomization to distant metastasis, a median of 2 years
Title
Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0
Time Frame
Within 3 months after initiation of radiation therapy
Title
Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0
Time Frame
Three months after initiation of radiation therapy
Title
Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire.
Time Frame
Throughout the study, an average of 2 years
Title
Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire.
Time Frame
Throughout the study, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Kong, MD
Phone
+8602138296666-53516
Email
lin.kong@sphic.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyi Hu, MD, PhD
Phone
+8602138296666-53516
Email
jiyi.hu@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiade J Lu, MD
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Kong, MD
Email
lin.kong@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Jiyi Hu, MD
Email
jiyi.hu@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Jiade J Lu, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.
IPD Sharing Time Frame
Within 5 years after the publication of the study.
IPD Sharing Access Criteria
Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of locally recurrent nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Learn more about this trial

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

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