Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

Study Overview
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Brief Summary
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This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

Detailed Description
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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 thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

Official Title
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A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma

Conditions
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Thymoma and Thymic Carcinoma

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Etoposide
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete resection within 3 months; Written informed consent. Exclusion Criteria: Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiochemotherapy<br>adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX) | Drug: Cisplatin<br>* 25mg/m2,iv gtt,d1-3<br>* Other names: DDP;Drug: Etoposide<br>* 75mg/m2,iv gtt,d1-3<br>* Other names: VP-16;Radiation: radiotherapy<br>* 60Gy/30Fx<br>|
| Sham Comparator: radiotherapy<br>adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX) | Radiation: radiotherapy<br>* 60Gy/30Fx<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | from registration to disease progression or death. | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thymoma, thymic carcinoma, adjuvant radiotherapy, adjuvant radiochemotherapy, incomplete resection