Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial… (NCT03663764) | Clinical Trial Compass
UnknownPhase 2
Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor
China57 participantsStarted 2018-08-13
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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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 j…