Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.
NCT ID: NCT02456506
Last Updated: 2020-03-24
Study Results
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Basic Information
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UNKNOWN
NA
142 participants
INTERVENTIONAL
2015-06-30
2023-03-31
Brief Summary
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Detailed Description
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Multiple retrospective and prospective studies have reported: under the condition of conventional fraction IMRT with the total dose of 60 gray (Gy) (division 27 times, once a day, every 2.2Gy), you can get a better local tumor control rate and survival outcome. However, the patients still underwent some severe late complications including nasopharyngeal necrosis, nasopharyngeal bleeding, temporal lobe necrosis, with the incidence rates of 28.8%, 18.6%, 20.3%, respectively. Approximately 50% of recurrent NPC patients died of these severe late complications, significantly compromising the overall survival rate of the patients. Previous studies showed that hyperfractionated radiotherapy could reduce severe late complication rates significantly, without affecting the local control rate. Indeed, we found that under the condition of equal irradiation time and tumor equivalent dosage between hyperfractionated IMRT (total dose of 65Gy, division 54 times, twice a day, once 1.2Gy, irradiation interval of 6-8 hours) and conventional fraction IMRT (total dose of 60Gy, division 27 times, once a day, every 2.2Gy), the normal late responding tissues equivalent dosage( EQD2) significantly decreased compared with conventional fraction IMRT. Therefore, the use of hyperfractionated IMRT is expected to decrease severe late complications rates, thereby improving the quality of life and overall survival of patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hyperfractionated IMRT Group
IMRT (total dose of 65Gy, division 54 times, twice a day, once 1.2Gy, irradiation interval of 6-8 hours)
Hyperfractionated IMRT
Conventional Fraction IMRT Group
IMRT (total dose of 60Gy, division 27 times, once a day, every 2.2Gy)
Conventional Fraction IMRT
Interventions
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Hyperfractionated IMRT
Conventional Fraction IMRT
Eligibility Criteria
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Inclusion Criteria
the interval time between initial treatment and relapse more than 1 year. recurrent Tumor stage2-4(rT2-4) Node stage0-2(rN0-2) Metastasis stage0(rM0) (rT2-4N0-2M0), overall stage II-IVa according to 2009 American Joint Committee on Cancer (AJCC/UICC) Tumor, Node, and Metastasis (TNM) staging system.
a Karnofsky performance status (KPS) score more than 70.
Exclusion Criteria
positive surgical margin after neck dissection. patients suffered with severe mental illness. severe diseases of the lung and cardiovascular system. severe hepatic and renal dysfunction.
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Ming-Yuan Chen
MD, PhD
Principal Investigators
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Ming-Yuan Chen, MD, PhD
Role: STUDY_CHAIR
Sun Yat-sen University
Yi Pan, MD, PhD
Role: STUDY_DIRECTOR
Guangdong Provincial People's Hospital
Dong-Ping Chen, MD, PhD
Role: STUDY_DIRECTOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Cummings BJ. Benefits of accelerated hyperfractionation for head and neck cancer. Acta Oncol. 1999;38(2):131-6. doi: 10.1080/028418699431528.
Jereczek-Fossa BA, Morra A, DeBraud F, Alterio D, Mazzetta C, Rocca A, Catalano G, Bianchi L, Pasetti M, Chiesa F, Bruschini R, Orecchia R. Hyperfractionated radiotherapy in locally advanced nasopharyngeal cancer. An analysis of 43 consecutive patients. Strahlenther Onkol. 2004 Jul;180(7):425-33. doi: 10.1007/s00066-004-1202-9.
Jian JJ, Cheng SH, Tsai SY, Yen KC, Chu NM, Chan KY, Tan TD, Cheng JC, Lin YC, Leu SY, Hsieh CI, Tsou MH, Lin CY, Huang AT. Improvement of local control of T3 and T4 nasopharyngeal carcinoma by hyperfractionated radiotherapy and concomitant chemotherapy. Int J Radiat Oncol Biol Phys. 2002 Jun 1;53(2):344-52. doi: 10.1016/s0360-3016(02)02709-8.
Toita T, Ogawa K, Kamata M, Kojya S, Itokazu T, Kakinohana Y, Iraha S, Yoshinaga M, Zukeran Y, Sawada S. Hyperfractionated radiotherapy followed by adjuvant chemotherapy for nasopharyngeal cancer: report of seven cases. Jpn J Clin Oncol. 1999 Mar;29(3):160-3. doi: 10.1093/jjco/29.3.160.
You R, Liu YP, Xie YL, Lin C, Duan CY, Chen DP, Pan Y, Qi B, Zou X, Guo L, Cao JY, Zhang YN, Wang ZQ, Liu YL, Ouyang YF, Wen K, Yang Q, Xie RQ, Li HF, Duan XT, Ding X, Peng L, Chen SY, Liang JL, Feng ZK, Xia TL, Xie RL, Jiang R, Gu CM, Liu RZ, Sun R, Yang X, Liu LZ, Ling L, Liu Q, Ng WT, Hua YJ, Huang PY, Chen MY. Hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy for patients with locally advanced recurrent nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2023 Mar 18;401(10380):917-927. doi: 10.1016/S0140-6736(23)00269-6. Epub 2023 Feb 23.
Other Identifiers
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SYSU5010
Identifier Type: -
Identifier Source: org_study_id
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