Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Not Applicable

Recruiting

• Conditions: Thymus Neoplasms
• Interventions: Radiation: Adjuvant Hypofractionation Radiotherapy

• Registration Number: NCT06189183
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

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 Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-11
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2030-12-31
• Study Completion: 2040-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjuvant Hypofractionation Radiotherapy	Adjuvant Hypofractionation Radiotherapy	Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	2 years, 5 years	From the date of resection to the date of disease recurrence or death

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years, 5 years	From the date of resection to the date of death
RadiotherapyToxicity	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
local recurrence	2 years, 5 years	recurrence of tumor bed
Intrathoracic recurrence / pleural metastasis	2 years, 5 years	Rate of Intrathoracic recurrence / pleural metastasis
metastasis free survival	2 years, 5 years	From the date of resection to the date of metastasis or death

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China