Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

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: Recruiting
• Conditions: Thymus Neoplasms
• Intervention / Treatment: Radiation: Adjuvant Hypofractionation Radiotherapy

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

• Study Contact: Name: Tao Zhang, Dr.; Phone Number: 8618911006677; Email: zhangt10@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
      • Contact: Tao Zhang, Dr.; Phone Number: 8618911006677; Email: zhangt10@126.com
      • Principal Investigator: Tao Zhang, Dr.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	From the date of resection to the date of death	2 years, 5 years
local recurrence	recurrence of tumor bed	2 years, 5 years
metastasis free survival	From the date of resection to the date of metastasis or death	2 years, 5 years
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
Intrathoracic recurrence / pleural metastasis	Rate of Intrathoracic recurrence / pleural metastasis	2 years, 5 years

Collaborators and Investigators

• 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

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): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adjuvant Radiotherapy; Thymus Neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Thoracic Neoplasms; Neoplasms, Complex and Mixed; Thymoma; Thymus Neoplasms
• 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