Hypofractionated Radiotherapy for Thymic Epithelial Tumors

NCT06692062 | Recruiting

• 1 other identifier: 202401009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

thymoma; hypofractionated radiotherapy; thymic carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• toxicity

  Patients were followed from enrollment until 3 years.

• 3-year OS

  The patients were followed up for 3 years from enrollment to death.

Study Arms (2)

Hypofractionated Radiotherapy

EXPERIMENTAL

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

Conventional Radiotherapy

NO INTERVENTION

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

Interventions

Hypofractionated Radiation Therapy RADIATION

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

Hypofractionated Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must provide written informed consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rongrong Zhou: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Thymoma; Thymus Neoplasms; Thymic epithelial tumor

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Rongrong Zhou, MD, PHD

CONTACT

+8613875898127; zhourr@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Department of Oncology

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)