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WBRT & Erlotinib in Advanced NSCLC and Brain Metastases (TACTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554775
Recruitment Status : Terminated (IDMC made a recommendation to stop the trial as the target for continuing to the 2nd phase was not met.)
First Posted : November 7, 2007
Last Update Posted : December 12, 2011
Cancer Research UK
Roche Pharma AG
Information provided by (Responsible Party):
University College, London

Brief Summary:

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib may also make tumor cells more sensitive to radiation therapy. It is not yet known whether giving whole-brain radiation therapy together with erlotinib is more effective than whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and brain metastases.

PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and erlotinib to see how well they work compared with whole-brain radiation therapy alone in treating patients with advanced non-small cell lung cancer and brain metastases.

Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Cancer Drug: erlotinib hydrochloride Drug: placebo Phase 2

Detailed Description:



  • Compare the effect of whole-brain radiotherapy (WBRT) and erlotinib hydrochloride vs WBRT alone on neurological progression-free survival at 2 months in patients with advanced non-small cell lung cancer and multiple brain metastases.


  • Compare the toxicity of these regimens.
  • Compare the response rate in these patients.
  • Compare quality of life of these patients.
  • Compare change in performance status in these patients.
  • Compare steroid dosing in these patients.
  • Compare sites of progression (cranial or extracranial) in these patients.

OUTLINE: This is a multicenter study. Patients are stratified by presence of extracranial metastases (yes vs no), RTOG recursive partitioning analysis (RPA) score (I vs II) and treatment center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily for 5 days. Patients also receive oral erlotinib hydrochloride once daily for up to 24 months.
  • Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once daily for up to 24 months.

Quality of life is assessed at baseline, monthly for 12 months, and then at 18 and 24 months.

After completion of study therapy, patients are followed every 1-2 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Phase II Double Blind Placebo Controlled Trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Multiple Brain Metastases [TACTIC]
Study Start Date : January 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: erlotinib hydrochloride
WBRT plus Tarceva (OSI-774, erlotinib) PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
Drug: erlotinib hydrochloride
PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
Other Names:
  • tarceva
  • OSI-774

Placebo Comparator: placebo
WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm
Drug: placebo
WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride

Primary Outcome Measures :
  1. Neurological progression-free survival at 2 months [ Time Frame: at 2 months ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: during and for 28 days following Tarceva/placebo treatment. ]
  2. Response rate [ Time Frame: from date of randomisation to radiological progression ]
  3. Quality of life [ Time Frame: completed monthly for the first 12 months and at 18 and 24 months from randomisation ]
  4. Change in performance status [ Time Frame: from baseline ]
  5. Steroid dosing [ Time Frame: from baseline ]
  6. Sites of progression (cranial or extracranial) [ Time Frame: from baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy
    • Relapsed NSCLC with newly diagnosed multiple brain metastases
    • Relapsed after second-line chemotherapy with newly diagnosed multiple brain metastases NOTE: *Biopsy of brain metastases is not required
  • Diagnosis of brain metastases must be confirmed by contrast CT scan or MRI within the past 4 weeks

    • Symptoms attributable to brain metastases
    • Patients who have undergone craniotomy with incomplete resection are eligible
  • Clinician certain that whole-brain radiotherapy (WBRT) will be beneficial
  • No evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
  • No more than 3 sites (organ systems) of extracranial metastases

    • No liver metastases


  • Karnofsky performance status 70-100%
  • RTOG recursive partitioning analysis (RPA) class I or II
  • Serum bilirubin < 2 times upper limit of normal (ULN)
  • AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
  • Creatinine < 5 times ULN
  • Able to take oral medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Caretaker able and willing to participate in the study
  • Patient and caretaker have access to a telephone and willing to respond to telephone interview
  • No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
  • No 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 including, but not limited to, any of the following:

    • Severe uncontrolled infection
    • Unstable angina
    • Myocardial infarction within the past month
    • Uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
    • Acute renal failure


  • See Disease Characteristics
  • At least 28 days since prior chemotherapy (for relapsed patients originally treated with chemotherapy)
  • No prior cranial radiotherapy
  • No prior anti-cancer EGFR therapy (e.g., erlotinib, gefitinib, or cetuximab)
  • No prior treatment for brain metastases (e.g., radiosurgery, radiotherapy, or chemotherapy)

    • Prior radiotherapy to the primary tumor and/or systemic treatment to metastatic sites of disease allowed
  • No concurrent cyclooxygenase-2 (COX-2) inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554775

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United Kingdom
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Salisbury District Hospital
Salisbury, England, United Kingdom, SP2 8BJ
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL18 5UJ
South West Wales Cancer Institute
Swansea, Wales, United Kingdom, SA2 8QA
Sponsors and Collaborators
University College, London
Cancer Research UK
Roche Pharma AG
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Study Chair: Siow M. Lee, MD, PhD, FRCP University College London Hospitals

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Responsible Party: University College, London Identifier: NCT00554775     History of Changes
Other Study ID Numbers: CDR0000573254
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011
Keywords provided by University College, London:
tumors metastatic to brain
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action