Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer

NCT01518621 | Terminated Phase 2

• 1 other identifier: RadEr
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.

Conditions

Cancer

Study Arms (2)

Radiotherapy alone

ACTIVE COMPARATOR

Total brain irradiation, 3Gy x10

Radiation: Radiation

Radiation plus erlotinib

EXPERIMENTAL

Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation

Drug: Radiation plus erlotinib

Interventions

Radiation RADIATION

Whole brain radiation

Also known as: Whole brain radiation therapy

Radiotherapy alone

Radiation plus erlotinib DRUG

Radiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation

Also known as: Whole brain radiation therapy and tyrosin kinase inhibitor

Radiation plus erlotinib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy
• Relapsed NSCLC with newly diagnosed multiple brain metastases
• Relapsed NSCLC after second-line or more chemotherapy regimens with newly diagnosed multiple brain metastases
• Diagnosis of brain metastases confirmed by MRI (or CT if MRI is not available/possible) within the past 4 weeks
• Symptoms attributable to brain metastases
• Patients who have undergone craniotomy with incomplete resection are eligible
• Clinician's opinion that whole-brain radiotherapy (WBRT) will be beneficial
• ECOG PS 0-2
• Age above 18 years
• Serum bilirubin \< 2 times upper limit of normal (ULN)
• AST and ALT \< 2 times ULN (\< 5 times ULN if liver metastases are present)
• Creatinine \< 1.5 times ULN
• Able to take oral medication
• Not pregnant or nursing
• Negative pregnancy test

You may not qualify if:

• More than 3 sites (organ systems) of extracranial metastases
• Evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
• Evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

The Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Radiation; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Physical Phenomena; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Odd Terje Brustugun, MD PhD

  Norwegian Radium Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 26, 2012
• Study Start: May 1, 2012
• Primary Completion: December 10, 2017
• Study Completion: December 10, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

NO (1)