Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether postoperative conformal radiotherapy are effective in the treatment of Masaoka stage II-III B type thymoma.

Detailed Description
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The role of postoperative radiotherapy in thymoma is controversial. Some retrospective studies were for the radiotherapy, but others were against. However, more inherent biases existed in these trials. Resection, Masaoka stage and pathology were widely accepted as the prognostic factors for thymoma. Furthermore, the frequency of local failure after radical resection was still high in Masaoka stage II-III B type thymoma. With the conformal technique appearing, conformal radiotherapy can escalate the dose without increasing the risk of normal tissue toxicities.

Official Title
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A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

Conditions
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Thymoma

Intervention / Treatment
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* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75, Zubrod-ECOG-WHO 0-2, the interval of surgery to radiotherapy < 2months, Masaoka stage II-III and WHO B type thymoma Exclusion Criteria: No second primary tumor, no serious comorbidity, no neoadjuvant anticancer treatment, no adjuvant chemotherapy.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy<br>postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma | Radiation: radiotherapy<br>* postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma<br>|
| No Intervention: observation<br>no treatment after radical resection for thymoma | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year local control rate | local control: tumor recurrence in the tumor bed 3 year local control rate: number of patients with tumor recurrence in the tumor bed at 3 years | 3 year after the end of all enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year failure-free and overall survival | failure-free survivail: the interval from the surgery and the recurrence within or out the tumor bed overall survival: the interval from the surgery and the death or lost of follow-up | 3 year after the end of all enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative, conformal, radiotherapy, thymoma