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NCT Number: NCT06189183

Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjuvant Hypofractionation Radiotherapy

Radiation

Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

Primary outcomes

  1. Disease Free Survival

    Time frame: 2 years, 5 years

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

Secondary outcomes

  1. Overall Survival

    Time frame: 2 years, 5 years

    From the date of resection to the date of death

  2. 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

  3. local recurrence

    Time frame: 2 years, 5 years

    recurrence of tumor bed

  4. Intrathoracic recurrence / pleural metastasis

    Time frame: 2 years, 5 years

    Rate of Intrathoracic recurrence / pleural metastasis

  5. metastasis free survival

    Time frame: 2 years, 5 years

    From the date of resection to the date of metastasis or death

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2040
First posted
Jan 3, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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