Actively Recruiting
A Prospective Study of Hypofractionated Radiotherapy for Thymic Epithelial Tumors
Led by Rongrong Zhou · Updated on 2024-11-18
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether hypofractionated radiotherapy can shorten treatment time without increasing side effects for patients with thymic epithelial tumors, including thymoma and thymic carcinoma. This study compares the effectiveness and safety of hypofractionated radiotherapy with conventional radiotherapy after surgery to treat these tumors. Participants will receive either hypofractionated or conventional radiotherapy following surgery. Hypofractionated radiotherapy delivers higher doses in fewer sessions, aiming to reduce overall treatment duration. The radiation doses vary based on the extent of tumor removal (R0, R1, or R2 resection), with different dose schedules for each group. The study does not use randomization, and patients choose their treatment group. During the study, participants will visit the hospital every 12 weeks for checkups and tests over a follow-up period of three years. Researchers will monitor disease progression, survival rates, and treatment toxicity. The main outcome measured is the three-year progression-free survival, with additional monitoring for overall survival and side effects to assess safety over the same period.
CONDITIONS
Brief Title
Hypofractionated Radiotherapy for Thymic Epithelial Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide written informed consent.
- Age between 18 and less than 75 years.
- Thymoma confirmed by pathology (types A, AB, B1, B2, B3) or thymic carcinoma.
- Masaoka2-Koga stage I to III.
- ECOG performance status of 0 to 2.
- Expected survival time greater than 1 year.
- Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during the trial.
- Patients must not be lactating.
- Sufficient bone marrow reserve and good function of important organs.
You will not qualify if you...
- Prior thoracic radiotherapy.
- Conditions unsuitable for radiotherapy such as recent myocardial infarction or active congestive heart failure.
- Uncontrolled infectious disease or serious medical or mental illness interfering with care.
- Other malignant tumors not under stable control.
- Known history of mental illness, substance abuse, or alcohol or drug abuse.
- Any other conditions deemed unsuitable for enrollment by the attending physician.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Radiotherapy duration varies by resection status, typically 8 to 35 fractions over several weeks
Participants receive hypofractionated radiotherapy or conventional radiotherapy after surgery to treat thymic epithelial tumors.
Multiple visits for radiotherapy sessions over the treatment course
Duration - Up to 3 years
Participants are followed for up to 3 years after treatment to monitor progression-free survival, overall survival, and toxicity.
Periodic follow-up visits for assessments
Trial Site Locations
Total: 1 location
1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
R
Rongrong Zhou, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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