A Phase 2/3 interventional study of Late-course accelerated hyperfractionated IMRT and Concomitant cisplatin chemotherapy in Nasopharyngeal Carcinoma, sponsored by Guangxi Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-08-21.
Sponsored by Guangxi Medical University · Phase 2/3, Interventional, and Treatment
Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's enrollment of 120 is above the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Guangxi Medical University is the lead sponsor of 68 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
Radiation: Late-course accelerated hyperfractionated IMRT · Drug: Concomitant cisplatin chemotherapy
Conventionally fractionated IMRT with concomitant cisplatin chemotherapy
Drug: Concomitant cisplatin chemotherapy · Radiation: Conventionally fractionated IMRT
1. IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease 2. IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately.
cisplatin:40mg/m2 weekly infusion for 6 weeks
IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.
Local/regional control rate, Acute and late toxicities
Time frame: 2-Yr
Overall survival rate
Time frame: 5-Yr
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Guangxi Medical University