Hypofractionated Radiotherapy for Thymic Epithelial Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRongrong Zhou
About this trial
The goal of this clinical trial is to learn if hypofractionated radiotherapy works to shorten the treatment time without increasing the side effects in patients of thymic epithelial tumors. The main questions it aims to answer are:
* Does Hypofractionated radiotherapy provide better results? * Can hypofractionated radiotherapy reduce toxic and side effects compared with conventional radiotherapy? Researchers will compare the efficacy and safety of hypofractionated radiotherapy after thymic tumor surgery.
Participants will:
* Receive hypofractionated radiotherapy or conventional radiotherapy * Visit the hospital regularly once every 12 weeks for checkups and tests
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must provide written informed consent.
18 years old ≤ age <75 years old.
Thymoma confirmed by pathology: type A, type AB, type B1, type B2, type B3. Thymic carcinoma. Patients with previous thymectomy were required to have complete surgical related data.
Masaoka⁃Koga ⁃ stage Ⅰ-Ⅲ
Disqualifiers
patients with prior thoracic radiotherapy;
diseases not suitable for radiotherapy, such as recent myocardial infarction, active congestive heart failure;
Uncontrolled infectious disease or other serious medical or mental illness that may interfere with care
Patients with other malignant tumors that are not under stable control;
Trial design
Design model
Parallel
Treatments tested in this trial
Hypofractionated Radiation Therapy
RadiationR0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Hypofractionated RadiotherapyExperimental treatment 1 intervention
Group B: Conventional RadiotherapyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
3-year PFS
Time from enrollment to disease progression or death.
Time frame
The patients were followed up for 3 years from enrollment to disease progression or death.Secondary outcomes
1
toxicity
Any adverse medical event that occurred between the time the patient provided informed consent and was enrolled in the trial and the date of the last follow-up visit.
Time frame
Patients were followed from enrollment until 3 years.2
3-year OS
Time from patient enrollment to patient death.
Time frame
The patients were followed up for 3 years from enrollment to death.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rongrong Zhou
Lead sponsor
Xiangya Hospital of Central South University
Sponsor institution
Source ClinicalTrials.gov