Locally Advanced ThymomaPhase 2NCT06924619
Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
A Phase 2 study testing neoadjuvant radiotherapy and cisplatin in people with Locally Advanced Thymoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Thymoma
- What is being tested?
- neoadjuvant radiotherapy and cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 1 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: A Prospective, Randomized, Controlled Phase Ⅱ Clinical Trial of Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
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:
- Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ?
- 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.
Read the 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
- Being tested
- neoadjuvant radiotherapy, cisplatin
- Keywords
- neoadjuvant radiotherapy, Locally Advanced Thymoma, neoadjuvant chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant radiotherapyRadiation
Target the primary tumor region with 40-50 Gy in 20-25 fractions.
cisplatinDrug
The cisplatin will be given concurrently with radiotherapy (25 mg/m² , D1, QW) for 4-5 cycles.
| Study group | Role | What they receive |
|---|---|---|
| the neoadjuvant radiotherapy group | Active comparator | This group will receive radiotherapy with 40-50 Gy in 20-25 fractions. Receives: 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. Receives: Radiation: neoadjuvant radiotherapy; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year
Secondary outcomes (3)
pCR rate
ypT0N0
Measured: up to 1 year
PFS
PFS measures the duration from the initiation of treatment to the point of disease progression, recurrence, or death from any cause.
Measured: up to 3 years
Safety and toxicities
Adverse events will be evaluated according to CTCAE v5.0 .
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start30 Oct 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced ThymomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924619
- Sponsor's protocol ID
- Y2024-1244
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Phase Ⅱ Clinical Trial of Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
- ClinicalTrials.gov ID
- NCT06924619
- Acronym / sponsor ID
- Y2024-1244
- Conditions
- Locally Advanced Thymoma
- Keywords
- neoadjuvant radiotherapy, Locally Advanced Thymoma, neoadjuvant chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the neoadjuvant radiotherapy group | Active comparator | Radiation: neoadjuvant radiotherapyThis group will receive radiotherapy with 40-50 Gy in 20-25 fractions. |
| the neoadjuvant chemoradiotherapy group | Experimental | Radiation: neoadjuvant radiotherapy, Drug: cisplatinThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant radiotherapyTarget the primary tumor region with 40-50 Gy in 20-25 fractions. | Radiation | the neoadjuvant chemoradiotherapy group, the neoadjuvant radiotherapy group |
| cisplatinThe cisplatin will be given concurrently with radiotherapy (25 mg/m² , D1, QW) for 4-5 cycles. | Drug | the neoadjuvant chemoradiotherapy group |
Primary outcome
Radical resection rate（R0）
Time frame: up to 1 year
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.
3 secondary outcomes
pCR rate
Time frame: up to 1 year
PFS
Time frame: up to 3 years
Safety and toxicities
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant radiotherapy and cisplatin in people with Locally Advanced Thymoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhang (+86-571-87783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radical resection rate（R0） (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.