Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor

Study Overview
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Brief Summary
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This phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).

Detailed Description
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HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used. All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy . Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Official Title
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Hypofractionated Radiotherapy Combined With Concurrent Weekly Chemotherapy and Thymosin α1 in Patients With Unresectable or Recurrent Thymic Epithelial Tumor: A Prospective, Single-arm Phase II Study

Conditions
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Thymoma and Thymic Carcinoma

Intervention / Treatment
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* Drug: Thymosin a1
* Radiation: hypofractionated radiotherapy
* Drug: concurrent chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors. Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Unresectable disease or recurrent intrathoracic disease which could be encompassed within radiation fields. White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN. FEV1 >0.8 L CB6 within normal limits Patients and their family signed the informed consents Exclusion Criteria: Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ. Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia). Malignant pleural effusion or pericardial effusion. Weight loss >10% within the past 3 months. Recruited in other clinical trials within 30 days Drug addiction, long-term alcohol abuse and AIDS patients. Uncontrollable epileptic attack or psychotic patients without self-control ability. Severe allergy or idiosyncrasy. Not suitable for this study judged by researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expeiment<br>HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used. All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy . Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy. | Drug: Thymosin a1<br>* All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.<br>Radiation: hypofractionated radiotherapy<br>* HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.<br>Drug: concurrent chemoradiotherapy<br>* All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life score | EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire | 1 year | 
| Overall Survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable or Recurrent Thymoma and Thymic Carcinoma, Hypofractionated Chemoradiotherapy, Thymosin a1