Hypofractionated Radiotherapy for Thymic Epithelial Tumors

NCT ID: NCT06692062

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-11-01

Brief Summary

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.

Conditions

Thymoma and Thymic Carcinoma; Thymoma; Thymic Cancer; Thymic Epithelial Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type: RADIATION

R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f

Conventional Radiotherapy

R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypofractionated Radiation Therapy

R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rongrong Zhou

OTHER

Sponsor Role: lead

Responsible Party

Rongrong Zhou

Deputy Director of Department of Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rongrong Zhou, MD, PHD

Role: CONTACT

zhourr@csu.edu.cn

+8613875898127

Facility Contacts

Rongrong Zhou, MD, PHD

Role: primary

zhourr@csu.edu.cn

+8613875898127

Other Identifiers

202401009

Identifier Type: -

Identifier Source: org_study_id