Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Second Affiliated Hospital of Hainan Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Hypofractionated radiotherapy

    Radiation

    The 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

24 Participants
are divided into 1 treatment group
Group A: Hypofractionated radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

overall response rate (ORR) in patients with nasopharyngeal carcinoma treated with Hypofractionated radiotherapy

Time frame
3 months, 6 months,12 months,24 months,36 months,60 months

Secondary outcomes

1

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.

Time frame
3 months, 6 months,12 months,24 months,36 months,60 months
2

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

Time frame
3 months, 6 months,12 months,24 months,36 months,60 months
3

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

Time frame
1-2 weeks, 3 months, 6 months
4

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

Time frame
2 weeks, 3 months, 6 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.