Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma

NCT ID: NCT06924619

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2029-05-01

Brief 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.

Detailed Description

For patients with thymoma, surgery is the optimal choice, and it has been proven to improve the survival rate of patients with thymoma. For locally advanced unresectable thymoma, direct surgical resection is associated with significant trauma, a high incidence of surgical complications, and a risk of postoperative recurrence. The application of neoadjuvant therapy is expected to reduce tumor volume and downstage the tumor, thereby increasing the rate of complete tumor resection (R0). Clinical practice has confirmed that thymic tumors are sensitive to both radiotherapy and chemotherapy. However, neoadjuvant chemotherapy regimens for thymoma have not been unified, and the available evidence recommends cisplatin based combination regimens. Earlier retrospective studies mainly targeting locally advanced unresectable thymoma suggested that neoadjuvant radiotherapy could achieve an R0 resection rate of about 50%-75% in these patients. In recent years, neoadjuvant chemoradiotherapy has shown promise in terms of objective response rate and R0 resection rate in patients with thymoma. There is still controversy over how to choose an appropriate neoadjuvant treatment protocol for such patients, and there is a lack of randomized prospective controlled studies.

In this prospective randomized controlled study, participants will be randomly assigned in a 1:1 ratio into two groups. One group will receive neoadjuvant radiotherapy alone, while the other group will receive the same radiotherapy regimen in combination with concurrent cisplatin chemotherapy. Participants in both groups will undergo standard surgery based on efficacy assessment. The purpose of this study is to evaluate the impact of these two approaches on the R0 resection rate in patients and to comprehensively assess the safety of the treatment modalities. This study also aims to provide clinical evidence for neoadjuvant treatment strategies in locally advanced unresectable thymoma.

Conditions

Locally Advanced Thymoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the neoadjuvant radiotherapy group

This group will receive radiotherapy with 40-50 Gy in 20-25 fractions.

Group Type: ACTIVE_COMPARATOR

neoadjuvant radiotherapy

Intervention Type: RADIATION

Target the primary tumor region with 40-50 Gy in 20-25 fractions.

the neoadjuvant chemoradiotherapy group

This group will receive concurrent chemotherapy with radiotherapy. The specific chemotherapy plan is to administer cisplatin intravenously at a dose of 25 mg/m² simultaneously on the first day of radiotherapy, followed by a 6-day rest period. 4-5 cycles of chemotherapy will be conducted, depending on the schedule of the radiotherapy.

Group Type: EXPERIMENTAL

neoadjuvant radiotherapy

Intervention Type: RADIATION

Target the primary tumor region with 40-50 Gy in 20-25 fractions.

cisplatin

Intervention Type: DRUG

The cisplatin will be given concurrently with radiotherapy (25 mg/m² , D1, QW) for 4-5 cycles.

Interventions

neoadjuvant radiotherapy

Target the primary tumor region with 40-50 Gy in 20-25 fractions.

Intervention Type: RADIATION

cisplatin

The cisplatin will be given concurrently with radiotherapy (25 mg/m² , D1, QW) for 4-5 cycles.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Zhang

Role: CONTACT

zezht@zju.edu.cn

+86-571-87783521

Other Identifiers

Y2024-1244

Identifier Type: -

Identifier Source: org_study_id