Know Cancer

or
forgot password

Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Lung Cancer, Metastatic Cancer

Thank you

Trial Information

Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer


Inclusion Criteria:



- Cytologic or histological diagnosis of non-small cell lung cancer

- Patients with disease progression after systemic chemotherapy with two-drug
combination regimens that includes a platinum agent or patients with EGFR mutation
status who have not been treated

- Patients are diagnosed with multiple brain metastases for the first time in 4 weeks

- Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).

- Doctors consider the patient will benefit from WBRT

- No prior brain radiotherapy

- ECOG performance status 0-2

- age:18-75 years

- Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L.
hemoglobin ≥90 g/L

- Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN)
Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5
times ULN (or less than or equal to 5 times ULN in case of known liver involvement)

- Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)

- Patients with measurable brain metastases according to the Response Evaluation
Criteria in Solid Tumors (RECIST) criteria

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study

Exclusion Criteria:

- Prior brain radiation therapy

- Solitary brain metastasis according to Magnetic resonance imaging (MRI)

- Mort than 3 extracranial organs have metastatic lesions

- Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are
permissible).

- pregnant or breast feeding women

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

partial response rate of intracranial lesions

Outcome Description:

Partial response rate of intracranial lesions will be measured.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Yun Fan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

ZhejiangCH-LCBM-1201

NCT ID:

NCT01514877

Start Date:

January 2012

Completion Date:

January 2016

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • tumors metastatic to brain
  • non-small cell lung cancer
  • Icotinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location