DRUG
TKI
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
Status
Unknown
Phase
Phase 2
Enrollment
46
Locations
1
Results
Not posted
Publications
0
Study summary
The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is also planned.
Interventions
DRUG
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
RADIATION
40-45 Gy/5-15f
DRUG
Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy.
Timeline
First posted
Jun 1, 2016
Study start
May 2016
Primary completion
Dec 2017
Study completion
May 2020
Results posted
Not reported
Registry updated
Nov 25, 2016
Outcomes
The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy
Time frame · 1-6 months
To assess the proportion of patients with an abscopal response (defined as at least a 30% decrease in the longest diameter of the best responding abscopal lesion) at 1-6 months after the radiation therapy
To assess the short-term quality of life (QOL)
Time frame · 4 months
FACT-E score at the 4 months after docetaxel consolidation therapy
Rate of CTCAE grade 2 or higher radiation pneumonitis
Time frame · 1 years
The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy
Overall Survival
Time frame · 2 years
Eligibility
Inclusion Criteria: * Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and showed stable disease after 3 months TKI, evaluated twice by PET/CT scan, brain MRI, and abdomen ultrasound (≥3 measurable lesions, and these lesions haven't received local therapy) * Age 18 years or older * ECOG Performance Status 0-2 * Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter * Patients and their family signed the informed consents Exclusion Criteria: * Received chemotherapy before TKI therapy * Brain parenchyma or leptomeningeal disease * Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment * Any medical co-morbidities that would preclude radiation therapy.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Publications
No PMID-linked publications were present in this registry snapshot.
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