Afatinib MET-PET/CT Study

Not Applicable

• Conditions: on-small-cell lung carcinoma

• Registration Number: JPRN-jRCTs031180271
• Lead Sponsor: Hanaoka Masayuki

Brief Summary

Afatinib was reduced SUVmax and LNRmax rate of metastases to brain.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1)Histologically or cytologically confirmed diagnosis of non-squamous cell and non-small cell lung cancer
2)Stage IV advanced unresectable, postoperative recurrent cancer
3)To detect following mutations by analysis of tissue or cell sample
4)Deletion in exon19 or L858R point mutation in exon 21 of EGFR gene
5)Brain metastasis verified by MRI or CT and >= 10 mm measurably
6)Using afatinib as first line treatment.
7)Age >= 20 years at obtained informed consent
8)ECOG performance status 0-2
9)The function of organs (marrow,liver,kidney,etc.)is maintained enough
10)Life expectancy >= 3 months

Exclusion Criteria

1)Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug pneumonia, etc. are complicated
2)Active other malignancy
3)Adjuvant chemotherapy
4)Infection to need to treat with antibiotics or antifungal agent via intravenous administration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate amino acid metabolic reactions obtained by followings <br>To evaluate MET-PET/CT at baseline (SUVmax,L/N ratio) <br>To evaluate MET-PET/CT at 4 and 8 weeks after start of therapy (SUVmax,L/N ratio)

Secondary Outcome Measures

Name	Time	Method
To evaluate relationship between amino acid metabolic reactions and following points <br>PFS <br>OS <br>Response rate <br>TTF <br>Disease control rate