Clinical trial NCT03663764: Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thymoma and Thymic Carcinoma
Keywords: Unresectable or Recurrent Thymoma and Thymic Carcinoma
Hypofractionated Chemoradiotherapy
Thymosin a1
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life score
timeFrame: 1 year
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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