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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Thymoma and Thymic Carcinoma

Treatments: Drug: Thymosin a1; Drug: concurrent chemoradiotherapy; Radiation: hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03663764

GASTO-1042

Details and patient eligibility

About

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).

Full 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.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

57 participants in 1 patient group

Expeiment

Experimental group

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.

Treatment:

Drug: Thymosin a1

Drug: concurrent chemoradiotherapy

Radiation: hypofractionated radiotherapy