Nasopharyngeal Cancinoma (NPC)Phase 3NCT06846450
Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC
A Phase 3 study testing Intensity-modulated proton radiation therapy, Intensity-modulated photon radiation therapy and Intensity-modulated carbon ion radiation therapy in people with Nasopharyngeal Cancinoma (NPC), run by Lin Kong, MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Intensity-modulated proton radiation therapy, Intensity-modulated photon radiation therapy and Intensity-modulated carbon ion radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201321
Lin Kong, 86-38296666, konglinjiang@163.com
Jiyi Hu, 86-38296666, jiyi.hu@sphic.org.cn
About this study
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).
Read the 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.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Intensity-modulated proton radiation therapy, Intensity-modulated photon radiation therapy, Intensity-modulated carbon ion radiation therapy, Concurrent chemotherapy, Induction chemotherapy
- Keywords
- Proton, Photon, Carbon ion, Phase 3 Trial, Locally Advanced NPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated proton radiation therapyRadiation
Also called IMPT
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 therapyRadiation
Also called IMRT
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 therapyRadiation
Also called IMCT
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 chemotherapyDrug
Concurrent chemotherapy will be administered on a weekly basis.
Induction chemotherapyDrug
Cisplatin-based induction chemotherapy will be administered every three weekly.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Radiation: Intensity-modulated proton radiation therapy; Radiation: Intensity-modulated carbon ion radiation therapy; Drug: Concurrent chemotherapy; Drug: Induction chemotherapy |
| Arm 2 | Active comparator | Not described Receives: Radiation: Intensity-modulated photon radiation therapy; Radiation: Intensity-modulated carbon ion radiation therapy; Drug: Concurrent chemotherapy; Drug: Induction chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (PFS) defined as the time interval from randomization to death or disease progression whichever comes first.
Measured: 3 years
Secondary outcomes (10)
Overall survival
Overall survival (OS) is defined as the time interval from randomization to death.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Prevalence of grade ≥2 acute toxicities
Prevalence of grade ≥2 acute toxicities graded by CTCAE v5.
Measured: 3 years
Prevalence of grade ≥3 acute toxicities
Prevalence of grade ≥3 acute toxicities graded by CTCAE v5.
Measured: 3 years
Prevalence of grade ≥2 late toxicities
Prevalence of grade ≥2 late toxicities graded by CTCAE v5.
Measured: 3 years
Prevalence of grade ≥3 late toxicities
Prevalence of grade ≥3 late toxicities graded by CTCAE v5.
Measured: 3 years
Functional Assessment of Cancer Therapy
Patient-reported outcome, Functional Assessment of Cancer Therapy (FACT).
Measured: 3 years
Xerostomia Questionnaire
Patient-reported outcome, Xerostomia Questionnaire (XQ).
Measured: 3 years
MD Anderson Dysphagia Inventory
Patient-reported outcome, MD Anderson Dysphagia Inventory (MADI).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Apr 2025
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin Kong, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Kong, MD, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846450
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2024-70
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant-level data will be shared, including detailed baseline characteristics, treatment information, and follow-up data on efficacy and toxicity profile.
Publications
Hu J, Huang Q, Gao J, Hu W, Yang J, Guan X, Qiu X, Zhang W, Kong L, Lu JJ. Mixed Photon and Carbon-Ion Beam Radiotherapy in the Management of Non-Metastatic Nasopharyngeal Carcinoma. Front Oncol. 2021 Jul 23;11:653050. doi: 10.3389/fonc.2021.653050. eCollection 2021.
PubMed 34367954Li X, Kitpanit S, Lee A, Mah D, Sine K, Sherman EJ, Dunn LA, Michel LS, Fetten J, Zakeri K, Yu Y, Chen L, Kang JJ, Gelblum DY, McBride SM, Tsai CJ, Riaz N, Lee NY. Toxicity Profiles and Survival Outcomes Among Patients With Nonmetastatic Nasopharyngeal Carcinoma Treated With Intensity-Modulated Proton Therapy vs Intensity-Modulated Radiation Therapy. JAMA Netw Open. 2021 Jun 1;4(6):e2113205. doi: 10.1001/jamanetworkopen.2021.13205.
PubMed 34143193Lewis GD, Holliday EB, Kocak-Uzel E, Hernandez M, Garden AS, Rosenthal DI, Frank SJ. Intensity-modulated proton therapy for nasopharyngeal carcinoma: Decreased radiation dose to normal structures and encouraging clinical outcomes. Head Neck. 2016 Apr;38 Suppl 1:E1886-95. doi: 10.1002/hed.24341. Epub 2015 Dec 26.
PubMed 26705956Vai A, Molinelli S, Rossi E, Iacovelli NA, Magro G, Cavallo A, Pignoli E, Rancati T, Mirandola A, Russo S, Ingargiola R, Vischioni B, Bonora M, Ronchi S, Ciocca M, Orlandi E. Proton Radiation Therapy for Nasopharyngeal Cancer Patients: Dosimetric and NTCP Evaluation Supporting Clinical Decision. Cancers (Basel). 2022 Feb 22;14(5):1109. doi: 10.3390/cancers14051109.
PubMed 35267415Minatogawa H, Yasuda K, Dekura Y, Takao S, Matsuura T, Yoshimura T, Suzuki R, Yokota I, Fujima N, Onimaru R, Shimizu S, Aoyama H, Shirato H. Potential benefits of adaptive intensity-modulated proton therapy in nasopharyngeal carcinomas. J Appl Clin Med Phys. 2021 Jan;22(1):174-183. doi: 10.1002/acm2.13128. Epub 2020 Dec 18.
PubMed 33338323Lin YH, Cheng JY, Huang BS, Luo SD, Lin WC, Chou SY, Juang PJ, Li SH, Huang EY, Wang YM. Significant Reduction in Vertebral Artery Dose by Intensity Modulated Proton Therapy: A Pilot Study for Nasopharyngeal Carcinoma. J Pers Med. 2021 Aug 22;11(8):822. doi: 10.3390/jpm11080822.
PubMed 34442466Taheri-Kadkhoda Z, Bjork-Eriksson T, Nill S, Wilkens JJ, Oelfke U, Johansson KA, Huber PE, Munter MW. Intensity-modulated radiotherapy of nasopharyngeal carcinoma: a comparative treatment planning study of photons and protons. Radiat Oncol. 2008 Jan 24;3:4. doi: 10.1186/1748-717X-3-4.
PubMed 18218078Widesott L, Pierelli A, Fiorino C, Dell'oca I, Broggi S, Cattaneo GM, Di Muzio N, Fazio F, Calandrino R, Schwarz M. Intensity-modulated proton therapy versus helical tomotherapy in nasopharynx cancer: planning comparison and NTCP evaluation. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):589-96. doi: 10.1016/j.ijrobp.2008.05.065.
PubMed 18793962Durante M, Loeffler JS. Charged particles in radiation oncology. Nat Rev Clin Oncol. 2010 Jan;7(1):37-43. doi: 10.1038/nrclinonc.2009.183. Epub 2009 Dec 1.
PubMed 19949433Moiseenko V, Wu J, Hovan A, Saleh Z, Apte A, Deasy JO, Harrow S, Rabuka C, Muggli A, Thompson A. Treatment planning constraints to avoid xerostomia in head-and-neck radiotherapy: an independent test of QUANTEC criteria using a prospectively collected dataset. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):1108-14. doi: 10.1016/j.ijrobp.2011.04.020. Epub 2011 Jun 2.
PubMed 21640505Beetz 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.
PubMed 22516776Zhou X, Ou X, Xu T, Wang X, Shen C, Ding J, Hu C. Effect of dosimetric factors on occurrence and volume of temporal lobe necrosis following intensity modulated radiation therapy for nasopharyngeal carcinoma: a case-control study. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):261-9. doi: 10.1016/j.ijrobp.2014.05.036. Epub 2014 Jul 24.
PubMed 25066214Chan SH, Ng WT, Kam KL, Lee MC, Choi CW, Yau TK, Lee AW, Chow SK. Sensorineural hearing loss after treatment of nasopharyngeal carcinoma: a longitudinal analysis. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1335-42. doi: 10.1016/j.ijrobp.2008.07.034. Epub 2008 Oct 14.
PubMed 18922648Wu LR, Liu YT, Jiang N, Fan YX, Wen J, Huang SF, Guo WJ, Bian XH, Wang FJ, Li F, Song D, Wu JF, Jiang XS, Liu JY, He X. Ten-year survival outcomes for patients with nasopharyngeal carcinoma receiving intensity-modulated radiotherapy: An analysis of 614 patients from a single center. Oral Oncol. 2017 Jun;69:26-32. doi: 10.1016/j.oraloncology.2017.03.015. Epub 2017 Apr 7.
PubMed 28559017Zheng Y, Han F, Xiao W, Xiang Y, Lu L, Deng X, Cui N, Zhao C. Analysis of late toxicity in nasopharyngeal carcinoma patients treated with intensity modulated radiation therapy. Radiat Oncol. 2015 Jan 13;10:17. doi: 10.1186/s13014-014-0326-z.
PubMed 25582731
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC
- ClinicalTrials.gov ID
- NCT06846450
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2024-70
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- Proton, Photon, Carbon ion, Phase 3 Trial, Locally Advanced NPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Lin Kong, MDUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: Intensity-modulated proton radiation therapy, Radiation: Intensity-modulated carbon ion radiation therapy, Drug: Concurrent chemotherapy, Drug: Induction chemotherapy |
| Arm 2 | Active comparator | Radiation: Intensity-modulated photon radiation therapy, Radiation: Intensity-modulated carbon ion radiation therapy, Drug: Concurrent chemotherapy, Drug: Induction chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-modulated proton radiation therapyAlso: IMPTIntensity-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. | Radiation | Arm 1 |
| Intensity-modulated photon radiation therapyAlso: IMRTIntensity-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. | Radiation | Arm 2 |
| Intensity-modulated carbon ion radiation therapyAlso: IMCTIntensity-modulated carbon ion radiation therapy will be delivered as a boost with a dose of 17.5 GyRBE in 5 fractions to gross tumor. | Radiation | Arm 1, Arm 2 |
| Concurrent chemotherapyConcurrent chemotherapy will be administered on a weekly basis. | Drug | Arm 1, Arm 2 |
| Induction chemotherapyCisplatin-based induction chemotherapy will be administered every three weekly. | Drug | Arm 1, Arm 2 |
Primary outcome
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.
10 secondary outcomes
Overall survival
Time frame: 3 years
Locoregional progression-free survival
Time frame: 3 years
Distant metastasis-free survival
Time frame: 3 years
Prevalence of grade ≥2 acute toxicities
Time frame: 3 years
Prevalence of grade ≥3 acute toxicities
Time frame: 3 years
Prevalence of grade ≥2 late toxicities
Time frame: 3 years
Prevalence of grade ≥3 late toxicities
Time frame: 3 years
Functional Assessment of Cancer Therapy
Time frame: 3 years
Xerostomia Questionnaire
Time frame: 3 years
MD Anderson Dysphagia Inventory
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 34367954Hu J, Huang Q, Gao J, Hu W, Yang J, Guan X, Qiu X, Zhang W, Kong L, Lu JJ. Mixed Photon and Carbon-Ion Beam Radiotherapy in the Management of Non-Metastatic Nasopharyngeal Carcinoma. Front Oncol. 2021 Jul 23;11:653050. doi: 10.3389/fonc.2021.653050. eCollection 2021.
- Background: PubMed 34143193Li X, Kitpanit S, Lee A, Mah D, Sine K, Sherman EJ, Dunn LA, Michel LS, Fetten J, Zakeri K, Yu Y, Chen L, Kang JJ, Gelblum DY, McBride SM, Tsai CJ, Riaz N, Lee NY. Toxicity Profiles and Survival Outcomes Among Patients With Nonmetastatic Nasopharyngeal Carcinoma Treated With Intensity-Modulated Proton Therapy vs Intensity-Modulated Radiation Therapy. JAMA Netw Open. 2021 Jun 1;4(6):e2113205. doi: 10.1001/jamanetworkopen.2021.13205.
- Background: PubMed 26705956Lewis GD, Holliday EB, Kocak-Uzel E, Hernandez M, Garden AS, Rosenthal DI, Frank SJ. Intensity-modulated proton therapy for nasopharyngeal carcinoma: Decreased radiation dose to normal structures and encouraging clinical outcomes. Head Neck. 2016 Apr;38 Suppl 1:E1886-95. doi: 10.1002/hed.24341. Epub 2015 Dec 26.
- Background: PubMed 35267415Vai A, Molinelli S, Rossi E, Iacovelli NA, Magro G, Cavallo A, Pignoli E, Rancati T, Mirandola A, Russo S, Ingargiola R, Vischioni B, Bonora M, Ronchi S, Ciocca M, Orlandi E. Proton Radiation Therapy for Nasopharyngeal Cancer Patients: Dosimetric and NTCP Evaluation Supporting Clinical Decision. Cancers (Basel). 2022 Feb 22;14(5):1109. doi: 10.3390/cancers14051109.
- Background: PubMed 33338323Minatogawa H, Yasuda K, Dekura Y, Takao S, Matsuura T, Yoshimura T, Suzuki R, Yokota I, Fujima N, Onimaru R, Shimizu S, Aoyama H, Shirato H. Potential benefits of adaptive intensity-modulated proton therapy in nasopharyngeal carcinomas. J Appl Clin Med Phys. 2021 Jan;22(1):174-183. doi: 10.1002/acm2.13128. Epub 2020 Dec 18.
- Background: PubMed 34442466Lin YH, Cheng JY, Huang BS, Luo SD, Lin WC, Chou SY, Juang PJ, Li SH, Huang EY, Wang YM. Significant Reduction in Vertebral Artery Dose by Intensity Modulated Proton Therapy: A Pilot Study for Nasopharyngeal Carcinoma. J Pers Med. 2021 Aug 22;11(8):822. doi: 10.3390/jpm11080822.
- Background: PubMed 18218078Taheri-Kadkhoda Z, Bjork-Eriksson T, Nill S, Wilkens JJ, Oelfke U, Johansson KA, Huber PE, Munter MW. Intensity-modulated radiotherapy of nasopharyngeal carcinoma: a comparative treatment planning study of photons and protons. Radiat Oncol. 2008 Jan 24;3:4. doi: 10.1186/1748-717X-3-4.
- Background: PubMed 18793962Widesott L, Pierelli A, Fiorino C, Dell'oca I, Broggi S, Cattaneo GM, Di Muzio N, Fazio F, Calandrino R, Schwarz M. Intensity-modulated proton therapy versus helical tomotherapy in nasopharynx cancer: planning comparison and NTCP evaluation. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):589-96. doi: 10.1016/j.ijrobp.2008.05.065.
- Background: PubMed 19949433Durante M, Loeffler JS. Charged particles in radiation oncology. Nat Rev Clin Oncol. 2010 Jan;7(1):37-43. doi: 10.1038/nrclinonc.2009.183. Epub 2009 Dec 1.
- Background: PubMed 21640505Moiseenko V, Wu J, Hovan A, Saleh Z, Apte A, Deasy JO, Harrow S, Rabuka C, Muggli A, Thompson A. Treatment planning constraints to avoid xerostomia in head-and-neck radiotherapy: an independent test of QUANTEC criteria using a prospectively collected dataset. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):1108-14. doi: 10.1016/j.ijrobp.2011.04.020. Epub 2011 Jun 2.
- Background: PubMed 22516776Beetz 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.
- Background: PubMed 25066214Zhou X, Ou X, Xu T, Wang X, Shen C, Ding J, Hu C. Effect of dosimetric factors on occurrence and volume of temporal lobe necrosis following intensity modulated radiation therapy for nasopharyngeal carcinoma: a case-control study. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):261-9. doi: 10.1016/j.ijrobp.2014.05.036. Epub 2014 Jul 24.
- Individual participant dataSharing planned: Yes. Anonymized individual participant-level data will be shared, including detailed baseline characteristics, treatment information, and follow-up data on efficacy and toxicity profile.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensity-modulated proton radiation therapy, Intensity-modulated photon radiation therapy and Intensity-modulated carbon ion radiation therapy in people with Nasopharyngeal Cancinoma (NPC), run by Lin Kong, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Kong (86-38296666, konglinjiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846450, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.