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

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).

Timeline

Start

2025-04-01

Primary completion

2031-01-31

Completion

2031-01-31

Publications

• Background 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.
• Background Li 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 Lewis 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 Vai 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 Minatogawa 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 Lin 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 Taheri-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 Widesott 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 Durante 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 Moiseenko 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 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.
• Background Zhou 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.
• Background Chan 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.
• Background Wu 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.
• Background Zheng 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.
• Background Tang LL, Guo R, Zhang N, Deng B, Chen L, Cheng ZB, Huang J, Hu WH, Huang SH, Luo WJ, Liang JH, Zheng YM, Zhang F, Mao YP, Li WF, Zhou GQ, Liu X, Chen YP, Xu C, Lin L, Liu Q, Du XJ, Zhang Y, Sun Y, Ma J. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA. 2022 Aug 23;328(8):728-736. doi: 10.1001/jama.2022.13997.
• Background Lv X, Cao X, Xia WX, Liu KY, Qiang MY, Guo L, Qian CN, Cao KJ, Mo HY, Li XM, Li ZH, Han F, He YX, Liu YM, Wu SX, Bai YR, Ke LR, Qiu WZ, Liang H, Liu GY, Miao JJ, Li WZ, Lv SH, Chen X, Zhao C, Xiang YQ, Guo X. Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):716-726. doi: 10.1016/S1470-2045(21)00075-9. Epub 2021 Apr 12.
• Background Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.
• Background Kong L, Zhang Y, Hu C, Guo Y, Lu JJ. Effects of induction docetaxel, platinum, and fluorouracil chemotherapy in patients with stage III or IVA/B nasopharyngeal cancer treated with concurrent chemoradiation therapy: Final results of 2 parallel phase 2 clinical trials. Cancer. 2017 Jun 15;123(12):2258-2267. doi: 10.1002/cncr.30566. Epub 2017 Feb 13.
• Background Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. doi: 10.1016/S1470-2045(18)30104-9. Epub 2018 Feb 28.
• Background Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.

Drugs

Indications