Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

August 24, 2020 updated by: Jiade J. Lu, Shanghai Proton and Heavy Ion Center

A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma

The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent [GyE]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201315
        • Recruiting
        • Shanghai Proton and Heavy Ion Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
  • Age ≥ 18 and ≤ 70 years of age.
  • 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.
  • Received radiotherapy for head and neck before.
  • Received surgery(except for biopsy) for primary lesion or cervical lymph node.
  • Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
  • Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
  • Accompanied with severe major organ dysfunction.
  • Presence of mental disease that may influence the understanding of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Photon combined with Carbon ion
The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
Radiation: Photon
Photon combined with Carbon ion in Arm 1
Radiation: Carbon ion
Same dose and fractionation will be used in both arms.
EXPERIMENTAL: Proton combined with Carbon ion
The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
Radiation: Carbon ion
Same dose and fractionation will be used in both arms.
Radiation: Proton
Proton combined with Carbon ion in Arm 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
Time Frame: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.
Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival of all patients
Time Frame: From randomization to death, a median of 3 years.
From randomization to death, a median of 3 years.
Progression-free survival of all patients
Time Frame: From randomization to death or disease progression, a median of 3 years.
From randomization to death or disease progression, a median of 3 years.
Local control
Time Frame: From randomization to local failure, a median of 3 years.
From randomization to local failure, a median of 3 years.
Regional control
Time Frame: From randomization to regional failure, a median of 3 years.
From randomization to regional failure, a median of 3 years.
Distant control
Time Frame: From randomization to distant failure, a median of 3 year.
From randomization to distant failure, a median of 3 year.
Treatment-related adverse events as assessed by NCI CTCAE v4.03
Time Frame: Time interval from start to 3 months after completion of radiotherapy.
Acute and late toxicities induced by radiation therapy other than xerostomia.
Time interval from start to 3 months after completion of radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Proton and Heavy Ion Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiade Lu, MD, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPHIC-TR-HNCNS-2019-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Pooled analysis comparing IMRT and particle beam radiotherapy will be of particular interest. 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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