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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]

Phase 2
18 Years
Not Enrolling
Lung Cancer, Metastatic Cancer

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Trial Information

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]



- 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

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

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Inclusion Criteria


- 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

- 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

- 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

- 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

- Prior radiotherapy to the primary tumor and/or systemic treatment to metastatic
sites of disease allowed

- No concurrent cyclooxygenase-2 (COX-2) inhibitors

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Neurological progression-free survival at 2 months

Outcome Time Frame:

at 2 months

Safety Issue:


Principal Investigator

Siow M. Lee, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2008

Completion Date:

November 2010

Related Keywords:

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