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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659578
• Other study ID #: GASTO-1043
• Status: Completed
• Phase: Phase 2
• Start date: August 9, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologic confirmation of NSCLC.
• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI.
• Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical irradiation.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Previously treated with chemotherapy or treatment-naive
• No previous chest radiotherapy, immunotherapy or biotherapy
• Hemoglobin=10 mg/dL, platelet=100000/µL,absolute neutrophil count =1500/µL
• Serum creatinine =1.25 times the upper normal limit(UNL), or creatinine clearance=60 ml/min
• Bilirubin =1.5 times UNL, AST(SGOT)=2.5 times UNL ,ALT(SGPT)=2.5 times UNL,alkaline phosphatase =5 times UNL
• FEV1 >0.8 L
• CB6 within normal limits
• patients and their family signed the informed consents

Exclusion Criteria:

• Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
• Contraindication for chemotherapy
• Malignant pleural or pericardial effusion.
• Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
• Women who has the probability of pregnancy without contraception
• Tendency of hemorrhage
• In other clinical trials within 30 days
• Addicted in drugs or alcohol, AIDS patients
• Uncontrollable seizure or psychotic patients without self-control ability
• Severe allergy or idiosyncrasy
• Not suitable for this study judged by researchers

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Pneumonia
• Small Cell Lung Carcinoma

Intervention

Drug:
• Concurrent chemotherapy
Concurrent chemotherapy consists of weekly docetaxel(25mg/?) and nedaplatin(25mg/?), each of 1 day's duration.

Radiation:
• split-course radiotherapy
Patient was administered with 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

Drug:
• thymosin alpha 1
subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Alpha diversity of gut microbiota as the exploratory outcome		From baseline to the end of CCRT, an average of 2 months
Primary	Incidence of =grade 2 radiation pneumonitis (CTCAE 5.0 version)	Radiation-induced pneumonitis except other reasons induced pneumonia	1-year
Secondary	Total lymphocyte count		From the beginning of CCRT until 6 months after the completion of CCRT.
Secondary	C-reaction protein		From the beginning of CCRT until 6 months after the completion of CCRT.
Secondary	grade of pulmonary fibrosis (CTCAE 5.0 version)		1-year

External Links

•   11. National Comprehensive Cancer Network. (NCCN) Clinical Practice Guidelines in Oncology. Small Cell Lung Cancer, Version