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

Phase 2

• Conditions: Thymoma and Thymic Carcinoma
• Interventions: Drug: Thymosin a1; Radiation: hypofractionated radiotherapy; Drug: concurrent chemoradiotherapy

• Registration Number: NCT03663764
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2018-08-13
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-27
• Last Update Posted: 2021-12-10
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Expeiment	hypofractionated 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. 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.
Expeiment	concurrent chemoradiotherapy	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.
Expeiment	Thymosin a1	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	2 years

Secondary Outcome Measures

Name	Time	Method
Quality of Life score	1 year	EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire
Overall Survival	2 years

Trial Locations

Locations (1)

Sun yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China