Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Thymus Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189183
• Other study ID #: NCC4287
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: December 31, 2040

Study information

• Verified date: November 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Tao Zhang, Dr.
• Phone: 8618911006677
• Email: zhangt10[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Thymoma
• Thymus Neoplasms

Intervention

Radiation:
• Adjuvant Hypofractionation Radiotherapy
Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival	From the date of resection to the date of disease recurrence or death	2 years, 5 years
Secondary	Overall Survival	From the date of resection to the date of death	2 years, 5 years
Secondary	RadiotherapyToxicity	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
Secondary	local recurrence	recurrence of tumor bed	2 years, 5 years
Secondary	Intrathoracic recurrence / pleural metastasis	Rate of Intrathoracic recurrence / pleural metastasis	2 years, 5 years
Secondary	metastasis free survival	From the date of resection to the date of metastasis or death	2 years, 5 years