Hypofractionated Radiotherapy for Thymic Epithelial Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Thymoma and Thymic Carcinoma, Thymoma, Thymic Cancer, Thymic Epithelial Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study of Hypofractionated Radiotherapy for Thymic Epithelial Tumors
Overview
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
Detailed description
According to the World Health Organization histological classification system, thymic epithelial tumors (TET) are divided into thymoma and thymic carcinoma. Surgery is the main treatment for thymic tumors, and radiotherapy (RT), as an important auxiliary method of surgery, also plays an irreplaceable role in all stages of thymoma.
Hypofractionated radiotherapy is a common mode of radiotherapy for thoracic tumors. Unlike conventional radiotherapy, hypofractionated radiotherapy has a higher single dose and a shorter course of treatment. Because it improves the treatment efficiency, it can reduce the treatment time of patients and medical institutions and the cost of patients.
In the postoperative radiotherapy stage, conventional radiotherapy and hypofractionated radiotherapy were used. The course of hypofractionated radiotherapy was shorter than that of conventional radiotherapy. Patients chose to accept hypofractionated radiotherapy as the hypofractionated group, but not the conventional group.
Interventions
- Radiation Hypofractionated Radiation Therapy
R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f
Primary outcome measures
- 3-year PFS [Time frame: The patients were followed up for 3 years from enrollment to disease progression or death.]
Secondary outcome measures (2)
- toxicity [Time frame: Patients were followed from enrollment until 3 years.]
- 3-year OS [Time frame: The patients were followed up for 3 years from enrollment to death.]
Eligibility criteria
Inclusion criteria
- 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
- ECOG performance status 0-2.
- Expected survival time > 1 year.
- Participants of childbearing age must agree to use effective contraception during the trial; In women of childbearing age, a serum or urine pregnancy test must be negative.
- Patients who are not lactating.
- Sufficient bone marrow reserve and good function of important organs.
Exclusion criteria
- 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;
- Known history of mental illness, substance abuse, alcohol or drug abuse.
- Other conditions deemed unsuitable for enrollment by the attending physician.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiangya Hospital, Central South University — Changsha
Identifiers
NCT: NCT06692062 · 202401009