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

ConditionNasopharyngeal Cancinoma (NPC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLin Kong, MD

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

470 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 4 interventions
Group B: Arm 2Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

Progression-free survival (PFS) defined as the time interval from randomization to death or disease progression whichever comes first.

Time frame
3 years

Secondary outcomes

1

Overall survival

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

Time frame
3 years
2

Locoregional progression-free survival

Locoregional progression-free survival (LRPFS) is defined as the time interval from randomization to death or locoregional failure whichever comes first.

Time frame
3 years
3

Distant metastasis-free survival

Distant metastasis-free survival (DMFS) is defined as the time interval from randomization to death or distant metastasis whichever comes first.

Time frame
3 years
4

Prevalence of grade ≥2 acute toxicities

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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lin Kong, MD

Lead sponsor

Shanghai Proton and Heavy Ion Center

Sponsor institution

Source ClinicalTrials.gov
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