Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

March 31, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection-Single Center Phase II Single Arm Clinical Trial

The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Adjuvant Radiotherapy(Postoperative radiotherapy) is proposed in stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.

Hypofractionation Radiotherapy is used in this study. The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Thymoma and Thymic carcinoma confirmed by histology or cytology
  • R0 resection (complete resection)
  • stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
  • Karnofsky performance status(KPS) 80, 90 or 100.
  • Having sufficient Pulmonary function, renal function and liver function. Neutrophile granulocyte count>1.5×109 /L, platelet count>80×109 /L, hemoglobin ≥10g/dL.

Exclusion Criteria:

  • Prior thoracic radiotherapy.
  • Uncontrolled Comorbidities.
  • Pregnant or nursing mother.
  • Pneumonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant Hypofractionation Radiotherapy
Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection
Radiation: Adjuvant Hypofractionation Radiotherapy
Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: 2 years, 5 years
From the date of resection to the date of disease recurrence or death
2 years, 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 2 years, 5 years
From the date of resection to the date of death
2 years, 5 years
local recurrence
Time Frame: 2 years, 5 years
recurrence of tumor bed
2 years, 5 years
metastasis free survival
Time Frame: 2 years, 5 years
From the date of resection to the date of metastasis or death
2 years, 5 years
RadiotherapyToxicity
Time Frame: 1 years, 2 years, 5 years
Rate of pneumonitis；Rate of esophagitis；Rate of skin reaction；Rate of myelitis；Rate of heart disease；Rate of vascular toxicity
1 years, 2 years, 5 years
Intrathoracic recurrence / pleural metastasis
Time Frame: 2 years, 5 years
Rate of Intrathoracic recurrence / pleural metastasis
2 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Tao Zhang, Dr., National Cancer Center/Cancer Hospital, CAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4287

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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