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

December 30, 2021 updated by: Hui Liu, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thymosin α1
Patients are 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)
Time Frame: 1-year
Radiation-induced pneumonitis except other reasons induced pneumonia
1-year

Secondary Outcome Measures

Outcome Measure
Time Frame
Total lymphocyte count
Time Frame: From the beginning of CCRT until 6 months after the completion of CCRT.
From the beginning of CCRT until 6 months after the completion of CCRT.
C-reaction protein
Time Frame: From the beginning of CCRT until 6 months after the completion of CCRT.
From the beginning of CCRT until 6 months after the completion of CCRT.
grade of pulmonary fibrosis (CTCAE 5.0 version)
Time Frame: 1-year
1-year

Other Outcome Measures

Outcome Measure
Time Frame
Alpha diversity of gut microbiota as the exploratory outcome
Time Frame: From baseline to the end of CCRT, an average of 2 months
From baseline to the end of CCRT, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

September 2, 2018

First Submitted That Met QC Criteria

September 2, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1043

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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