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NCT Number: NCT06846450

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

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).

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Key information

Conditions

Nasopharyngeal Cancinoma (NPC)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensity-modulated proton radiation therapy

Radiation

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

Intensity-modulated photon radiation therapy

Radiation

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

Intensity-modulated carbon ion radiation therapy

Radiation

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

Concurrent chemotherapy

Drug

Concurrent chemotherapy will be administered on a weekly basis.

Induction chemotherapy

Drug

Cisplatin-based induction chemotherapy will be administered every three weekly.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

    Overall survival (OS) is defined as the time interval from randomization to death.

  2. 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. 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.

  4. Prevalence of grade ≥2 acute toxicities

    Time frame: 3 years

    Prevalence of grade ≥2 acute toxicities graded by CTCAE v5.

  5. Prevalence of grade ≥3 acute toxicities

    Time frame: 3 years

    Prevalence of grade ≥3 acute toxicities graded by CTCAE v5.

  6. Prevalence of grade ≥2 late toxicities

    Time frame: 3 years

    Prevalence of grade ≥2 late toxicities graded by CTCAE v5.

  7. Prevalence of grade ≥3 late toxicities

    Time frame: 3 years

    Prevalence of grade ≥3 late toxicities graded by CTCAE v5.

  8. Functional Assessment of Cancer Therapy

    Time frame: 3 years

    Patient-reported outcome, Functional Assessment of Cancer Therapy (FACT).

  9. Xerostomia Questionnaire

    Time frame: 3 years

    Patient-reported outcome, Xerostomia Questionnaire (XQ).

  10. MD Anderson Dysphagia Inventory

    Time frame: 3 years

    Patient-reported outcome, MD Anderson Dysphagia Inventory (MADI).

Study contacts

Contact information is provided by the study sponsor or research team.

Jiyi Hu

CONTACT

[email protected]

86-38296666

Lin Kong

CONTACT

[email protected]

86-38296666

Sponsors and collaborators

Lead sponsor

Lin Kong, MD

Other

Registry information

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Feb 26, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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