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

NCT07691619 | Recruiting Phase 2

• 1 other identifier: E20260837
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thymic Epithelial Tumor

Keywords

Thymic Epithelial Tumors; Postoperative Hypofractionated Radiotherapy

Outcome Measures

Primary Outcomes (1)

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

  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).

  Up to 3 months

Secondary Outcomes (9)

• Disease-Free Survival

  Up to 3 years

• Overall Survival

  Up to 3 years

• Locoregional Recurrence Rate

  Up to 3 years

• Distant Metastasis Rate

  Up to 3 years

• All-Cause Mortality Rate

  Up to 3 years

Other Outcomes (1)

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

  From baseline to up to 3 years after radiotherapy

Study Arms (1)

RT

EXPERIMENTAL

Radiation: Postoperative hypo-fractionated radiotherapy

Interventions

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.

RT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Thymic epithelial tumor

Study Officials

• Wencheng Zhang, M.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wencheng Zhang, M.D.

CONTACT

+86 022 23340123; zhangwencheng@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 9, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)