Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

NCT06189183 | Active Not Recruiting

• 1 other identifier: NCC4287
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thymus Neoplasms

Keywords

Thymus Neoplasms; Adjuvant Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  From the date of resection to the date of disease recurrence or death

  2 years, 5 years

Secondary Outcomes (5)

• Overall Survival

  2 years, 5 years

• RadiotherapyToxicity

  1 years, 2 years, 5 years

• local recurrence

  2 years, 5 years

• Intrathoracic recurrence / pleural metastasis

  2 years, 5 years

• metastasis free survival

  2 years, 5 years

Study Arms (1)

Adjuvant Hypofractionation Radiotherapy

EXPERIMENTAL

Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Radiation: Adjuvant Hypofractionation Radiotherapy

Interventions

Adjuvant Hypofractionation Radiotherapy RADIATION

Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Adjuvant Hypofractionation 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:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Thymus Neoplasms

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Tao Zhang, Dr.

  National Cancer Center/Cancer Hospital, CAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: November 11, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)