Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer

NCT01724801 | Completed Phase 3

• 1 other identifier: CTONG1201
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

Brief Summary

EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with EGFR-mutant non-small cell lung cancer.

Conditions

Brain Metastasis; Non Small Cell Lung Cancer

Keywords

EGFR mutant

Outcome Measures

Primary Outcomes (1)

• iPFS

  intracranial progression-free survival

  18 months

Secondary Outcomes (5)

• progress-free survival (PFS)

  up to 16 months

• time of controlling brain metastasis symptom

  18months

• Response rate of brain metastasis

  12months

• Cognitive function

  18months

• overall survival(OS)

  24months

Other Outcomes (1)

• Toxicity

  24months

Study Arms (2)

icotinib

EXPERIMENTAL

icotinib administered orally at a dose of 125 mg 3 times daily

Drug: Icotinib

Whole brain irradiation

ACTIVE COMPARATOR

Whole brain irradiation 30Gy/3Gy/10 fractions plus concurrent or sequential chemotherapy for 4-6 cycles

Radiation: whole brain radiation(WBI)

Interventions

whole brain radiation(WBI) RADIATION

WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles

Whole brain irradiation

Icotinib DRUG

administered orally at a dose of 125 mg 3 times daily

icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology.
• Patient who brain metastases was shown in MRI or CT scan. Brain metastases lesions should be more than 3.The diameter among these lesions should be more than 1 centimeter.
• Males or females aged ≥18 years, \< 75 years. Eastern Cooperative Oncology Group(ECOG) performance status 0-1. Life expectancy ≥12 weeks. The therapy of surgery,chemotherapy,radiotherapy that the patients were ever received should be more than 2 weeks ago.The patient had recovered from the treatment.
• Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Written informed consent provided.

You may not qualify if:

• Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
• Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.
• Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
• Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
• Female subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
• Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT )and Aspartate Aminotransferase (AST )\< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
• The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment.
• Patient need increase irradiation dose after routine irradiation(30GY/10f/2w) Patient should treat extra cranial lesions first. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead
• Guangdong Provincial People's Hospital: collaborator

Study Sites (2)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Yang JJ, Zhou C, Huang Y, Feng J, Lu S, Song Y, Huang C, Wu G, Zhang L, Cheng Y, Hu C, Chen G, Zhang L, Liu X, Yan HH, Tan FL, Zhong W, Wu YL. Icotinib versus whole-brain irradiation in patients with EGFR-mutant non-small-cell lung cancer and multiple brain metastases (BRAIN): a multicentre, phase 3, open-label, parallel, randomised controlled trial. Lancet Respir Med. 2017 Sep;5(9):707-716. doi: 10.1016/S2213-2600(17)30262-X. Epub 2017 Jul 19.

  PMID: 28734822 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jinji Yang, MD

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2012
• First Posted: November 12, 2012
• Study Start: October 14, 2012
• Primary Completion: June 30, 2015
• Study Completion: September 14, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

CN (2)