Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC

November 24, 2025 updated by: Lin Kong, MD
The goal of this phase 3 non-inferiority trial is to compare the efficacy and toxicity of proton or photon radiation therapy plus carbon ion radiation therapy for newly diagnosed nasopharyngeal carcinoma. The main question it aims to answer is that if proton radiation therapy plus carbon ion radiation therapy is non-inferior to photon radiation therapy plus carbon ion radiation therapy in terms of therapeutic efficacy. Participants will be randomized to receive either proton radiation therapy (arm 1) or photon radiation therapy (arm 2), in addition to carbon ion radiation therapy (for both arms).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase 3 randomized non-inferiority trial. The primary objective of the trial is to compare progression-free survival between proton plus carbon ion radiation therapy (arm 1) and photon plus carbon ion radiation therapy (arm 2) for patients with newly diagnosed nasopharyngeal carcinoma (NPC). The secondary objectives includes overall survival, locoregional progression-free survival, distant metastasis-free survival, physician-graded toxicities according to the CTCAE, and patients-reported outcomes. This study adopts a web-based central randomization system. The randomization method uses minimization, with two balancing factors: Stage (AJCC Staging System, 9th edition): Stage I vs. Stages II/III; Response to induction chemotherapy: No induction chemotherapy vs. sensitive (CR + PR) vs. resistant (SD + PD). Eligible patients will be randomized in a 1:1 ratio into either the experimental group or the control group. This is an open-label study, meaning both patients and investigators are aware of the treatment allocation.

Participants randomized to arm 1 will receive proton therapy with a dose of 56 GyRBE in 28 fractions, in addition to a boost delivered using carbon ion radiation therapy with a dose of 17.5 GyRBE in 5 fractions. Participants randomized to arm 2 will receive photon therapy with a dose of 56 Gy in 28 fractions, plus carbon ion radiation therapy with a dose of 17.5 GyRBE in 5 fractions. The treatment response will be evaluated according to the RECIST criteria.

Induction chemotherapy and concurrent chemotherapy will be prescribed according to disease stage.

Study Type

Interventional

Enrollment (Estimated)

470

Phase

  • Phase 3

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 Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201321
        • Recruiting
        • Shanghai Proton and Heavy Ion Center
        • Principal Investigator:
          • Lin Kong
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jiyi Hu

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Willingness to sign the written informed consent.
  • Pathologically confirmed Nasopharyngeal carcinoma.
  • Patients with any stage of disease except distant metastasis.
  • Age: ≥ 18 and ≤ 70 years old.
  • Eastern Cooperative Oncology Group score: 0-1.
  • Adequate laboratory test results.
  • Willingness to accept adequate contraception.

Exclusion criteria:

  • Presence of distant metastasis.
  • Previous radiotherapy to head and neck region.
  • Previous surgery (except for biopsy) for the primary lesion or cervical lymph nodes.
  • History of malignant tumor within the past 5 years.
  • Presence of multiple primary tumors.
  • Presence of diseases that may interfere with the evaluation of study endpoints.
  • Presence of severe major organ dysfunction.
  • Mental illness that may affect 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Radiation: Intensity-modulated carbon ion radiation therapy
Intensity-modulated carbon ion radiation therapy will be delivered as a boost with a dose of 17.5 GyRBE in 5 fractions to gross tumor.
Other Names:
  • IMCT
Drug: Concurrent chemotherapy
Concurrent chemotherapy will be administered on a weekly basis.
Drug: Induction chemotherapy
Cisplatin-based induction chemotherapy will be administered every three weekly.
Radiation: Intensity-modulated photon radiation therapy
Intensity-modulated photon therapy, will be delivered to the high risk area with a dose of 56 Gy in 28 fractions, and if applicable, to the low risk area with a dose of 50.4 Gy in 28 fractions.
Other Names:
  • IMRT
Experimental: Arm 1
Radiation: Intensity-modulated proton radiation therapy
Intensity-modulated proton therapy, will be delivered to the high risk area with a dose of 56 GyRBE in 28 fractions, and if applicable, to the low risk area with a dose of 50.4 GyRBE in 28 fractions.
Other Names:
  • IMPT
Radiation: Intensity-modulated carbon ion radiation therapy
Intensity-modulated carbon ion radiation therapy will be delivered as a boost with a dose of 17.5 GyRBE in 5 fractions to gross tumor.
Other Names:
  • IMCT
Drug: Concurrent chemotherapy
Concurrent chemotherapy will be administered on a weekly basis.
Drug: Induction chemotherapy
Cisplatin-based induction chemotherapy will be administered every three weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 years
Progression-free survival (PFS) defined as the time interval from randomization to death or disease progression whichever comes first.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
Overall survival (OS) is defined as the time interval from randomization to death.
3 years
Locoregional progression-free survival
Time Frame: 3 years
Locoregional progression-free survival (LRPFS) is defined as the time interval from randomization to death or locoregional failure whichever comes first.
3 years
Distant metastasis-free survival
Time Frame: 3 years
Distant metastasis-free survival (DMFS) is defined as the time interval from randomization to death or distant metastasis whichever comes first.
3 years
Prevalence of grade ≥2 acute toxicities
Time Frame: 3 years
Prevalence of grade ≥2 acute toxicities graded by CTCAE v5.
3 years
Prevalence of grade ≥3 acute toxicities
Time Frame: 3 years
Prevalence of grade ≥3 acute toxicities graded by CTCAE v5.
3 years
Prevalence of grade ≥2 late toxicities
Time Frame: 3 years
Prevalence of grade ≥2 late toxicities graded by CTCAE v5.
3 years
Prevalence of grade ≥3 late toxicities
Time Frame: 3 years
Prevalence of grade ≥3 late toxicities graded by CTCAE v5.
3 years
Functional Assessment of Cancer Therapy
Time Frame: 3 years
Patient-reported outcome, Functional Assessment of Cancer Therapy (FACT).
3 years
Xerostomia Questionnaire
Time Frame: 3 years
Patient-reported outcome, Xerostomia Questionnaire (XQ).
3 years
MD Anderson Dysphagia Inventory
Time Frame: 3 years
Patient-reported outcome, MD Anderson Dysphagia Inventory (MADI).
3 years

Collaborators and Investigators

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

Sponsor

Lin Kong, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2025

Primary Completion (Estimated)

January 31, 2031

Study Completion (Estimated)

January 31, 2031

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPHIC-TR-HNCNS-2024-70

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant-level data will be shared, including detailed baseline characteristics, treatment information, and follow-up data on efficacy and toxicity profile.

IPD Sharing Time Frame

Anonymized IPD will be shared within 3 years after publication of the primary, secondary and safety results of the study.

IPD Sharing Access Criteria

Data may be shared with qualified researchers 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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