Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.
Multiple Centre, Randomised, Controlled Trial of Hyperfractionated IMRT and Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.
1 other identifier
interventional
142
1 country
1
Brief Summary
This study evaluates the hyperfractionated IMRT in the treatment of patients with locally recurrent nasopharyngeal carcinoma. Half of participants will receive hyperfractionated IMRT, while the other half will receive conventional fraction IMRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMarch 24, 2020
March 1, 2020
7.5 years
May 25, 2015
March 21, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Overall survival rate
3 year
Severe late complications rate
2 year
Secondary Outcomes (3)
Quality of life questionnaire
2 year
Loco-regional relapse free survival rate
3 year
Distant metastasis free survival rate
3 year
Study Arms (2)
Hyperfractionated IMRT Group
EXPERIMENTALIMRT (total dose of 65Gy, division 54 times, twice a day, once 1.2Gy, irradiation interval of 6-8 hours)
Conventional Fraction IMRT Group
ACTIVE COMPARATORIMRT (total dose of 60Gy, division 27 times, once a day, every 2.2Gy)
Interventions
Eligibility Criteria
You may qualify if:
- histologically approved WHO III patients received radical radiotherapy initially before recurrence (irradiation dosage \> 66 Gy).
- 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.
You may not qualify if:
- a history of previous or synchronous malignant tumors. recurrent Node stage3(rN3), recurrent Metastasis stage1(rM1) according to 2009 AJCC/UICC TNM staging system.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Related Publications (5)
Cummings BJ. Benefits of accelerated hyperfractionation for head and neck cancer. Acta Oncol. 1999;38(2):131-6. doi: 10.1080/028418699431528.
PMID: 10227432BACKGROUNDJereczek-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.
PMID: 15241530BACKGROUNDJian 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.
PMID: 12023138BACKGROUNDToita 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.
PMID: 10225700BACKGROUNDYou 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.
PMID: 36842439DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ming-Yuan Chen, MD, PhD
Sun Yat-sen University
- STUDY DIRECTOR
Yi Pan, MD, PhD
Guangdong Provincial People's Hospital
- STUDY DIRECTOR
Dong-Ping Chen, MD, PhD
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 25, 2015
First Posted
May 28, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2022
Study Completion
March 1, 2023
Last Updated
March 24, 2020
Record last verified: 2020-03