Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Study Overview
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Brief Summary
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This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Detailed Description
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Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Official Title
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Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Conditions
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Thymoma and Thymic Carcinoma

Intervention / Treatment
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* Radiation: concurrent chemoradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18 75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent. Exclusion Criteria: Distant metastases could not be encompassed within a tolerable radiotherapy field; Underwent surgery, radiotherapy or chemotherapy before entering this study ; Have other malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Intensity modulated radiotherapy with VP-16/Cisplatin
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemoradiation<br>concurrent chemoradiation. | Radiation: concurrent chemoradiation<br>* The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | from registration to death as a result of any cause. | 2 years | 
| Progression free survival | from registration to first documentation of disease progression or death. | 2 years | 
| Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0 | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thymoma, thymic carcinoma, chemoradiotherapy, inoperable