About this trial
The purpose of this study was to evaluate the efficacy and safety of large fractionation radiotherapy in nasopharyngeal carcinoma patients, and to analyze whether Hypofractionated radiotherapy is not inferior to conventional radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, male or female;
Performance status ≤ 2 ;
Nasopharyngeal cancer patients diagnosed by pathology (including histology or cytology) , of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, whether TNM staging);
Have at least one evaluable lesion (according to Recist1.1 criteria)
Disqualifiers
Pregnant or lactating women
As determined by the investigators, there were severe comorbidities that could not tolerate or complete radiation therapy.
There are contraindications in MRI;
Second primary malignancy exists;
Trial design
Single group
Treatments tested in this trial
Hypofractionated radiotherapy
RadiationThe patients with nasopharyngeal carcinoma were given the dose of large segmentation radiotherapy, 2.64Gy/ time, 5 times/week, a total of 25 times, a total of 66Gy/5 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate (ORR)
overall response rate (ORR) in patients with nasopharyngeal carcinoma treated with Hypofractionated radiotherapy
Secondary outcomes
Overall survival (months)
This is defined as the number of months participants survived from completion date of radiation therapy until the date of death. If a participant is alive, the participant censored at the date of last documentation of the patient being alive.
Progress-free survival (months)
This is defined as the number of months participants experienced no locoregional recurrence or distant metastasis from completion date of radiation therapy until the date of progression. The date of progression will be defined as the date of initial suspicion for progression by physical exam or imaging studies.Evaluation of Incidence of Treatment-Emergent Adverse Events Patients will be educated and instructed to report any adverse events
Number acute toxicities
Number of acute toxicities associated with radiation experienced by participants based on the follow-up assessments at 1-2 weeks, 3 months, 6 months following radiation therapy completion
Number of chronic toxicities
Number of chronic toxicities associated with radiation experienced by participants based on the follow-up assessments completed at 2 weeks, 3 months, 6 months and 12 months following radiation therapy
Sponsors and contacts
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