Hypofractionated Radiotherapy for Thymic Epithelial Tumors

A Prospective Study of Hypofractionated Radiotherapy for Thymic Epithelial Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Thymoma; Thymic Epithelial Tumor; Thymic Cancer; Thymoma and Thymic Carcinoma
• Intervention / Treatment: Radiation: Hypofractionated Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rongrong Zhou, MD, PHD; Phone Number: +8613875898127; Email: zhourr@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Xiangya Hospital, Central South University
      • Contact: Rongrong Zhou, MD, PHD; Phone Number: +8613875898127; Email: zhourr@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated Radiotherapy; R0 resection: 42-48 Gy/14-16f or 40-44 Gy or 10-11f,40 Gy/8f R1 resection: 48-51 Gy/16-17f or 44-48 Gy/11-12f or 40-45 Gy/8-9f R2 resection: 51-60 Gy/17-20f or 48-56 Gy/12-14f or 45 -60Gy/9-12f	Radiation: Hypofractionated Radiation Therapy; R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f
No Intervention: Conventional Radiotherapy; R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year PFS	Time from enrollment to disease progression or death.	The patients were followed up for 3 years from enrollment to disease progression or death.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patients were followed from enrollment until 3 years.
3-year OS	Time from patient enrollment to patient death.	The patients were followed up for 3 years from enrollment to death.

Collaborators and Investigators

• Sponsor: Rongrong Zhou

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: hypofractionated radiotherapy; thymoma; thymic carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Thoracic Neoplasms; Lymphatic Diseases; Neoplasms, Complex and Mixed; Neoplasms, Glandular and Epithelial; Thymus Neoplasms; Thymoma
• Other Study ID Numbers: 202401009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No