Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma

Neoplasm Metastasis

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients take EGFR-TKI alone till tumor progression

After 3 mos TKI, patients with limited metastatic take EGFR-TKI concurrent with hypofractionated radiotherapy till tumor progression.

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid

EGFR-TKI

Thoracic Hypofractionated Radiotherapy

Shenglin Ma, MD

To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.

Rational:

After inductive TKI therapy in NSCLC with sensitizing EGFR mutations, the residual lesion might be the source of subsequent disease progression, defined as acquired resistance to TKI. Two reasons can be used to explain the formation of the residual lesion：1）there is a subgroup of cancer cells that are not sensitive to TKI therapy because of tumor heterogeneity, like de novo T790M mutation; 2)some cancer cells can keep static state during the beginning treatment, and then develops acquired resistance to TKI therapy under the long-term drug pressure and continue to re-proliferation. From this point of view, elimination of residual lesion provides the chance to reduce or slow the possibility of developing resistance to TKI.

Objective:

To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.

A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy

A Phase II Trial of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy

We will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy.

FACT-E score at the 4 months after docetaxel consolidation therapy

First People's Hospital of Hangzhou

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy	NCT02788058	Lung Adenocarci... EGFR Positive N...	EGFR-TKI Thoracic Hypofr...	18 Years - 75 Years	First People's Hospital of Hangzhou
A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy	NCT02788058	Lung Adenocarci... EGFR Positive N...	EGFR-TKI Thoracic Hypofr...	18 Years - 75 Years	First People's Hospital of Hangzhou

Spots Global Cancer Trial Database for limited metastases