Thymoma and Thymic Carcinoma
Conditions
Keywords
Unresectable or Recurrent Thymoma and Thymic Carcinoma, Hypofractionated Chemoradiotherapy, Thymosin a1
Brief summary
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
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.
Interventions
DRUGThymosin a1
All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
RADIATIONhypofractionated radiotherapy
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.
DRUGconcurrent chemoradiotherapy
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life score | 1 year | EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire |
| Overall Survival | 2 years | — |
Countries
China
Outcome results
None listed