Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Apr 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different treatment approaches for patients with locally advanced thymoma, a type of tumor in the thymus gland that cannot be surgically removed. The trial compares neoadjuvant radiotherapy (radiation therapy before surgery) to neoadjuvant chemoradiotherapy (a combination of radiation and chemotherapy before surgery). Researchers want to find out which method helps more patients achieve complete removal of the tumor during surgery and whether adding chemotherapy affects the safety of the treatment.

To participate in this trial, individuals must be between 18 and 75 years old and have a confirmed diagnosis of thymoma that is classified as stage III-IV A, meaning it is advanced and cannot be surgically removed at the moment. Participants should have no prior treatment for their thymoma and must be in good overall health. During the trial, participants will receive either of the two treatment methods and be monitored for how well the treatment works and any side effects they may experience. This study is currently recruiting participants and aims to not only help improve treatment options for thymoma but also explore the possibility of less invasive surgical techniques.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥18 years and ≤75 years.
• • Histologically confirmed thymoma of Masaoka-Koga stage III-IV A.
• • Assessed as unresectable thymoma by a thoracic surgeon prior to treatment.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• • No prior anti-thymoma treatment, including but not limited to systemic chemotherapy, radiotherapy, surgery, or immunotherapy.
• • Presence of at least one measurable lesion according to RECIST v1.1 criteria.
• • Cardiopulmonary function compatible with surgery.
• • Expected survival of \>3 months.
• • Comprehensive evaluation completed within 28 days before enrollment in the study, with a full blood cell test obtained within 15 days, demonstrating normal visceral organ function and normal bone marrow function.
• • Negative serum or urine pregnancy test for women of childbearing potential within 14 days before study enrollment.
• • Willingness of the patient to sign an informed consent form and to adhere to the specified follow-up schedule.
• Exclusion Criteria:
• • Histologically confirmed thymic neuroendocrine tumor.
• • Currently participating in an interventional clinical study that may affect this study, or having received other investigational drugs or devices within 4 weeks prior to the first treatment in this study.
• • Pregnant or breastfeeding women.
• • Previous history of thoracic radiotherapy.
• • Deemed unsuitable for three-dimensional conformal or intensity-modulated radiotherapy by a radiation oncology specialist.
• • History of allogeneic bone marrow or organ transplantation.
• • History of malignancies other than thymoma within the past 3 years, or untreated other primary malignancies.
• • Serious comorbidities that would affect the study treatment.
• • Any history or evidence of disease, treatment, or abnormal laboratory values that could interfere with the study results or prevent the participant from completing the study, or other situations deemed unsuitable for enrollment by the investigator.