Clinical trial NCT06846450: Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With Locally Advanced NPC
Official title: Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With Locally Advanced NPC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Cancinoma (NPC)
Keywords: Proton
Photon
Carbon ion
Phase 3 Trial
Locally Advanced NPC
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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).

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 locoregionally advanced 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. 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 will be randomized in a 1:1 ratio to either arm 1 or arm 2. 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. All participants will also receive induction chemotherapy and concurrent chemotherapy. The treatment response will be evaluated according to the RECIST criteria.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Locoregional progression-free survival
timeFrame: 3 years
measure: Distant metastasis-free survival
timeFrame: 3 years
measure: Prevalence of grade ≥2 acute toxicities
timeFrame: 3 years
measure: Prevalence of grade ≥3 acute toxicities
timeFrame: 3 years
measure: Prevalence of grade ≥2 late toxicities
timeFrame: 3 years
measure: Prevalence of grade ≥3 late toxicities
timeFrame: 3 years
measure: Functional Assessment of Cancer Therapy
timeFrame: 3 years
measure: Xerostomia Questionnaire
timeFrame: 3 years
measure: MD Anderson Dysphagia Inventory
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
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