Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma

NCT06924619 | Recruiting Phase 2 DMC

• 1 other identifier: Y2024-1244
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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. 1.Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ?
2. 2.The safety and adverse reactions of neoadjuvant radiotherapy? Does the addition of neoadjuvant chemotherapy have an impact on this?

Conditions

Locally Advanced Thymoma

Keywords

neoadjuvant radiotherapy; Locally Advanced Thymoma; neoadjuvant chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Radical resection rate（R0）

  The tumor lesion is completely resected, with no residual tumor visible to the naked eye at the surgical margins, and no cancer cells detectable at the margins under the microscope.

  up to 1 year

Secondary Outcomes (3)

• pCR rate

  up to 1 year

• PFS

  up to 3 years

• Safety and toxicities

  up to 3 years

Study Arms (2)

the neoadjuvant radiotherapy group

ACTIVE COMPARATOR

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

Radiation: neoadjuvant radiotherapy

the neoadjuvant chemoradiotherapy group

EXPERIMENTAL

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.

Radiation: neoadjuvant radiotherapy; Drug: cisplatin

Interventions

neoadjuvant radiotherapy RADIATION

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

the neoadjuvant chemoradiotherapy group; the neoadjuvant radiotherapy group

cisplatin DRUG

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

the neoadjuvant chemoradiotherapy group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy; Cisplatin

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Ting Zhang

CONTACT

+86-571-87783521; zezht@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 11, 2025
• Study Start: October 30, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 24, 2025

Record last verified: 2025-01

Locations

CN (1)