Using hypofractionated radiotherapy for thymic epithelial tumors

A Prospective Study of Hypofractionated Radiotherapy for Thymic Epithelial Tumors

This study is testing if a shorter, more intense type of radiation therapy can help people with thymic epithelial tumors after surgery feel better and have fewer side effects compared to the standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06692062 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of hypofractionated radiotherapy compared to conventional radiotherapy in patients with thymic epithelial tumors following surgery. The study will assess whether hypofractionated radiotherapy can provide better treatment outcomes while reducing side effects and overall treatment time. Participants will receive either hypofractionated or conventional radiotherapy and will have regular follow-up visits every 12 weeks for monitoring. The goal is to determine if the shorter treatment course of hypofractionated radiotherapy can improve patient care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed thymoma or thymic carcinoma who have undergone surgery and meet specific health criteria.

Not a fit: Patients with prior thoracic radiotherapy or those with serious medical conditions that preclude radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more efficient treatment for patients with thymic epithelial tumors, reducing both treatment time and side effects.

How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy in treating thoracic tumors, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients must provide written informed consent.
2. 18 years old ≤ age \<75 years old.
3. 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.
4. Masaoka⁃Koga ⁃ stage Ⅰ-Ⅲ
5. ECOG performance status 0-2.
6. Expected survival time \> 1 year.
7. 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.
8. Patients who are not lactating.
9. Sufficient bone marrow reserve and good function of important organs.

Exclusion Criteria:

1. patients with prior thoracic radiotherapy;
2. diseases not suitable for radiotherapy, such as recent myocardial infarction, active congestive heart failure;
3. Uncontrolled infectious disease or other serious medical or mental illness that may interfere with care
4. Patients with other malignant tumors that are not under stable control;
5. Known history of mental illness, substance abuse, alcohol or drug abuse.
6. Other conditions deemed unsuitable for enrollment by the attending physician.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital, Central South University — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Rongrong Zhou, MD, PHD

Conditions: Thymoma and Thymic Carcinoma, Thymoma, Thymic Cancer, Thymic Epithelial Tumor, thymoma, hypofractionated radiotherapy, thymic carcinoma