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NCT Number: NCT07691619

Hypofractionated Radiotherapy After Complete Resection for Stage II/III Thymic Epithelial Tumors

This is a prospective, open-label, single-arm Phase II study designed to evaluate the safety of postoperative hypofractionated radiotherapy in patients with Stage II/III thymic epithelial tumors after complete resection. After a screening period of up to 28 days, eligible patients will receive adjuvant hypofractionated radiotherapy to a total dose of 40 Gy in 15 fractions, delivered once daily at 2.67 Gy per fraction, 5 days per week over 3 weeks. The study will primarily assess treatment-related safety and tolerability, with preliminary evaluation of efficacy, economic burden, and quality of life.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Wencheng Zhang, M.D.

CONTACT

[email protected]

+86 022 23340123 ext. 1121

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who voluntarily agree to participate in this study, sign the informed consent form, demonstrate good compliance, and are willing to comply with scheduled follow-up visits.
  • Age 18-75 years, male or female.
  • Histopathologically confirmed thymoma or thymic carcinoma after R0 complete resection. Eligible disease stages according to the Masaoka-Koga staging system include Stage II-III thymic carcinoma, Stage IIA Type B3 thymoma, Stage IIB Type B2/B3 thymoma, and Stage III thymoma.
  • Eastern Cooperative Oncology Group performance status of 0-1.
  • Life expectancy of at least 3 months.
  • Adequate major organ function to meet the requirements of study treatment, including bone marrow, hepatic, renal, and coagulation function according to protocol-specified criteria.
  • Patients with reproductive potential must agree to use medically acceptable contraception during study treatment and for 6 months after completion of study treatment. Female patients of childbearing potential must have a negative pregnancy test before enrollment and must not be breastfeeding.

Exclusion criteria

  • Patients who do not meet the protocol-specified requirements for pathological type, disease stage, or histological subtype.
  • Patients who have not undergone surgical treatment, or who underwent R1 or R2 resection, or who have definite gross residual disease.
  • Prior thoracic radiotherapy.
  • Major surgery other than the tumor resection procedure or severe trauma within 4 weeks before the first radiotherapy treatment.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Prior or ongoing non-protocol-specified antitumor therapy, including immunotherapy, targeted therapy, radiotherapy, or other investigational treatment.
  • Active autoimmune disease or a history of severe autoimmune disease that, in the investigator's judgment, makes the patient unsuitable for radiotherapy.
  • History of immunodeficiency, including HIV positivity, history of organ transplantation, or history of allogeneic bone marrow transplantation.
  • Uncontrolled severe cardiovascular disease, such as New York Heart Association Class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or severe arrhythmia requiring clinical intervention.
  • Severe infection within 4 weeks before the first radiotherapy treatment, or active pulmonary inflammation indicated by baseline imaging.
  • History of interstitial lung disease, history of non-infectious pneumonitis, or Grade 3 or higher pulmonary dysfunction confirmed by pulmonary function testing.
  • Active pulmonary tuberculosis, active hepatitis B infection, or active hepatitis C infection.
  • Diagnosis of another malignancy before the first radiotherapy treatment, except for low-risk malignancies that have been adequately treated.
  • Any other condition that, in the investigator's judgment, may affect patient safety, compliance, or the collection of study data.

Treatment and study plan

Postoperative hypo-fractionated radiotherapy

Radiation

The investigational treatment consists of postoperative hypofractionated radiotherapy delivered at a total dose of 40 Gy in 15 fractions (2.67 Gy per fraction), administered 5 days per week.

Primary outcomes

  1. Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events

    Time frame: Up to 3 months

    Percentage of participants who experience treatment-related Grade 2 or higher acute adverse events from the start of radiotherapy to 3 months after completion of radiotherapy, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).

Secondary outcomes

  1. Disease-Free Survival

    Time frame: Up to 3 years

    Time from the start of radiotherapy to the first documented disease recurrence, distant metastasis, or death from any cause, whichever occurs first.

  2. Overall Survival

    Time frame: Up to 3 years

    Time from the start of radiotherapy to death from any cause.

  3. Locoregional Recurrence Rate

    Time frame: Up to 3 years

    ercentage of participants who develop locoregional recurrence during follow-up. Locoregional recurrence includes recurrence in the tumor bed, mediastinum, pleura, or regional lymph nodes, as assessed by imaging, pathology, or clinical evaluation.

  4. Distant Metastasis Rate

    Time frame: Up to 3 years

    Percentage of participants who develop distant metastasis during follow-up, as assessed by imaging, pathology, or clinical evaluation.

  5. All-Cause Mortality Rate

    Time frame: Up to 3 years

    Percentage of participants who die from any cause during follow-up.

  6. Incidence of Treatment-Related Late Adverse Events

    Time frame: From 6 months after completion of radiotherapy to 3 years

    Percentage of participants who experience treatment-related late adverse events occurring 6 months or later after completion of radiotherapy, including pulmonary, cardiac, esophageal, or other late adverse events, assessed according to NCI-CTCAE v5.0.

  7. Total Economic Cost

    Time frame: Up to 3 years

    Total economic cost per participant during the study period, including direct medical costs, non-medical costs, and indirect costs. Direct medical costs include radiotherapy costs, radiotherapy-related symptomatic treatment costs, and costs for the management of toxic and adverse reactions. Non-medical and indirect costs include transportation costs, accommodation costs, and lost work or companion time costs. Costs will be calculated in Chinese Yuan.

  8. Quality of Life Score Assessed by EORTC QLQ-C30

    Time frame: Up to 3 years

    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The global health status/quality of life score will be recorded at baseline and predefined follow-up visits. Scores range from 0 to 100, with higher scores indicating better global health status/quality of life.

  9. Swallowing Function Score Assessed by the Standardized Swallowing

    Time frame: Up to 3 years

    Swallowing function will be assessed using the Standardized Swallowing Assessment (SSA). The total SSA score will be recorded at baseline and predefined follow-up visits, with higher scores indicating worse swallowing function.

Other outcomes

  1. Odds Ratios for Cardiac-Related Disease Occurrence According to Predefined Cardiac and Coronary Artery Dose Parameters

    Time frame: From baseline to up to 3 years after radiotherapy

    Odds ratios for cardiac-related disease occurrence per 1-Gy increase in predefined cardiac and coronary artery dose parameters will be estimated using logistic regression. Predefined dose parameters will include mean heart dose and coronary artery substructure dose parameters, measured in Gray (Gy) from the radiotherapy treatment plan. Cardiac-related disease occurrence will be defined as the occurrence of clinically diagnosed cardiac disease or cardiac adverse events during follow-up, assessed by clinical cardiac evaluation and NCI-CTCAE v5.0. Cardiac-related diseases or adverse events may include coronary artery disease, myocardial ischemia or infarction, arrhythmia, heart failure, pericardial disease, or other clinically diagnosed cardiac events.

Study contacts

Contact information is provided by the study sponsor or research team.

Wencheng Zhang, M.D.

CONTACT

[email protected]

+86 022 23340123 ext. 1121

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

A Prospective, Single-Arm Phase II Clinical Study of Hypofractionated Adjuvant Radiotherapy After Complete Resection for Stage II/III Thymic Epithelial Tumors

Acronym: TET-HFRT40

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jul 9, 2026
Registry last updated
Jul 10, 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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