Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
A Prospective, Randomized, Controlled Phase Ⅱ Clinical Trial of Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
Second Affiliated Hospital, School of Medicine, Zhejiang University
178 participants
Oct 30, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this prospective, randomized, controlled phase II clinical study is to evaluate the efficacy and safety of neoadjuvant radiotherapy in patients with locally advanced unresectable thymoma. The main questions it aims to answer are: 1. Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ? 2. The safety and adverse reactions of neoadjuvant radiotherapy? Does the addition of neoadjuvant chemotherapy have an impact on this? Participants will be randomly divided into two groups: one group will receive neoadjuvant radiotherapy, and the other will receive neoadjuvant chemoradiotherapy. The primary endpoint of the study is to evaluate the radical resection rate (R0) of two groups. The secondary endpoints will include the pathological complete response rate (pCR), 3-year progression-free survival, and safety and toxicities. In addition, this study will explore the feasibility and completion rate of minimally invasive surgical resection.
Eligibility
Inclusion Criteria11
- 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 Criteria9
- 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.
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Interventions
Target the primary tumor region with 40-50 Gy in 20-25 fractions.
The cisplatin will be given concurrently with radiotherapy (25 mg/m² , D1, QW) for 4-5 cycles.
Locations(1)
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NCT06924619