Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC
NCT ID: NCT06846450
Last Updated: 2025-12-02
Study Results
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Basic Information
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RECRUITING
PHASE3
470 participants
INTERVENTIONAL
2025-04-01
2031-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Arm 1
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.
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.
Concurrent chemotherapy
Concurrent chemotherapy will be administered on a weekly basis.
Induction chemotherapy
Cisplatin-based induction chemotherapy will be administered every three weekly.
Arm 2
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.
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.
Concurrent chemotherapy
Concurrent chemotherapy will be administered on a weekly basis.
Induction chemotherapy
Cisplatin-based induction chemotherapy will be administered every three weekly.
Interventions
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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.
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.
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.
Concurrent chemotherapy
Concurrent chemotherapy will be administered on a weekly basis.
Induction chemotherapy
Cisplatin-based induction chemotherapy will be administered every three weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Lin Kong, MD
OTHER
Responsible Party
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Lin Kong, MD
Chief physician
Locations
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Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Beetz I, Schilstra C, van der Schaaf A, van den Heuvel ER, Doornaert P, van Luijk P, Vissink A, van der Laan BF, Leemans CR, Bijl HP, Christianen ME, Steenbakkers RJ, Langendijk JA. NTCP models for patient-rated xerostomia and sticky saliva after treatment with intensity modulated radiotherapy for head and neck cancer: the role of dosimetric and clinical factors. Radiother Oncol. 2012 Oct;105(1):101-6. doi: 10.1016/j.radonc.2012.03.004. Epub 2012 Apr 18.
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Other Identifiers
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SPHIC-TR-HNCNS-2024-70
Identifier Type: -
Identifier Source: org_study_id
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