Spots Global Cancer Trial Database for Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

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Trial Identification

Brief Title: Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Official Title: A Phase II Study of Thymopeptide a1 During Split-course Chemoradiotherapy to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Study ID: NCT03659578

Conditions

Non-small Cell Lung Cancer

Interventions

Concurrent chemotherapy

split-course radiotherapy

thymosin alpha 1

Study Description

Brief Summary: This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.

Detailed Description: This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of radiation pneumonitis in non-small cell lung cancer with bulky tumor. All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost. Patients were further treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. Toxicities will be graded according to CTCAE v. 4.0.