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Metastatic Malignant Neoplasm in the BrainPhase 3NCT00096265

Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Erlotinib Hydrochloride and Stereotactic Radiosurgery in people with Metastatic Malignant Neoplasm in the Brain and Recurrent Non-Small Cell Lung Carcinoma, run by National Cancer Institute (NCI) at 83 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3-Dimensional Conformal Radiation Therapy, Erlotinib Hydrochloride and Stereotactic Radiosurgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
83 sitesin 2 countries
Study dates
6 Oct 2004to 1 Apr 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed non-small cell lung cancer
  • One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
  • Well circumscribed tumor(s)
  • Maximum diameter ≤ 4.0 cm
  • If multiple lesions are present and one lesion is at the maximum diameter, the other lesions must not exceed 3.0 cm in maximum diameter
  • No metastases within 10 mm of the optic apparatus such that a portion of the optic nerve or chiasm would be included in the high-dose stereotactic radiosurgery boost field
Show all 57Show fewer
  • No metastases in the brainstem, midbrain, pons, or medulla
  • No prior complete resection of all known brain metastases
  • Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter
  • No clinical or radiographic evidence of progression (other than study lesion[s]) within the past month
  • Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease
  • Stable extracranial metastases allowed
  • No known or pre-existing liver metastases
  • No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
  • Synchronous brain metastases at initial diagnosis allowed
  • Performance status - Zubrod 0-1
  • Hemoglobin ≥ 8 g/dL
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST < 2 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases
  • Total bilirubin normal
  • Lactic dehydrogenase < 2 times ULN
  • Creatinine < 1.5 times ULN
  • No clinically active interstitial lung disease
  • Chronic stable asymptomatic radiographic changes allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Neurologic function status 0-2
  • No other major medical illness or psychiatric impairment that would preclude study participation
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to erlotinib or temozolomide
  • No concurrent immunotherapy
  • No concurrent biologic therapy, excluding growth factors and epoetin alfa
  • No prior temozolomide or erlotinib
  • No other concurrent chemotherapy during study radiotherapy
  • Other concurrent chemotherapy allowed after study radiotherapy, except for the following:
  • Temozolomide or erlotinib (arm I only)
  • Erlotinib (arm II only)
  • Temozolomide (arm III only)
  • No prior cranial radiotherapy
  • No concurrent intensity-modulated radiotherapy
  • Concurrent radiotherapy to painful bone lesions allowed
  • No concurrent radiotherapy to more than 15% of bone marrow
  • No other concurrent therapy for brain metastases unless a recurrence is detected
  • More than 30 days since prior investigational drugs
  • No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following (for patients randomized to receive erlotinib):
  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Phenobarbital
  • Primidone
  • Oxcarbazepine
  • No other concurrent investigational drugs
  • No concurrent Hypericum perforatum (St. John's wort)
  • No drugs that alter gastric pH (e.g., proton pump inhibitors or H2 antagonists) within 4 hours after erlotinib administration (arm III patients only)

Who cannot join

None listed.

Trial locations and contacts

83 sites in 2 countries.

83 sites in 2 countries

United States80 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Finley Hospital

    Dubuque, Iowa, 52001

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Unity Hospital

    Fridley, Minnesota, 55432

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Franciscan Saint Margaret Health-Hammond Campus

    Hammond, Indiana, 46320

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network-Southside Cancer Center

    Jacksonville, Florida, 32207

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network-Florida Cancer Center Beaches

    Jacksonville Beach, Florida, 32250

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Norton Suburban Hospital and Medical Campus

    Louisville, Kentucky, 40207

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • 21st Century Oncology-Orange Park

    Orange Park, Florida, 32073

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • 21st Century Oncology-Palatka

    Palatka, Florida, 32177

  • Bay Medical Center

    Panama City, Florida, 32401

  • Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, 19103

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Wheaton Franciscan Cancer Care - All Saints

    Racine, Wisconsin, 53405

  • Riverview Medical Center/Booker Cancer Center

    Red Bank, New Jersey, 07701

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • University of Rochester

    Rochester, New York, 14642

  • Integrated Community Oncology Network-Flager Cancer Center

    Saint Augustine, Florida, 32086

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona, 85260

  • Scottsdale Health Care-Osborn

    Scottsdale, Arizona, 85260

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Sparta Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Saint John's Hospital

    Springfield, Illinois, 62702

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Tallahassee Memorial HealthCare

    Tallahassee, Florida, 32308

  • Natalie Warren Bryant Cancer Center at Saint Francis

    Tulsa, Oklahoma, 74136

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Reading Hospital

    West Reading, Pennsylvania, 19611

Other trials in United States

Canada3 sites

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Ottawa Hospital-Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases

This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor. It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Compare survival in patients with non-small cell lung cancer and brain metastases treated with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or erlotinib.

SECONDARY OBJECTIVES:

  1. Compare time to CNS progression in patients treated with these regimens. II. Compare quality-adjusted survival in patients treated with these regimens. III. Compare 3-month quality of life in patients treated with these regimens. IV. Compare the 6-month performance status of patients treated with these regimens.
  2. Compare 6-month steroid dependence in patients treated with these regimens. VI. Compare cause of death (neurologic vs other) in patients treated with these regimens.

VII. Determine the effects of non-protocol chemotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and the presence of extracranial metastases (< 65 years old AND no extracranial metastases vs ≥ 65 years old OR extracranial metastases), number of metastases (1 vs 2 or 3), and extent of extracranial disease (none vs present). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.

ARM II: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.

In all arms, patients with recurrent brain metastases may undergo additional stereotactic radiosurgery.

Quality of life is assessed at baseline and at 3, 6, 9, 12, 18, and 24 months.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Being tested
3-Dimensional Conformal Radiation Therapy, Erlotinib Hydrochloride, Stereotactic Radiosurgery, Temozolomide
Medical subject headings
Brain Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-Dimensional Conformal Radiation TherapyRadiation

    Also called 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT

    Patients undergo radiation therapy once daily for approximately 3 weeks

  • Erlotinib HydrochlorideDrug

    Also called Cp-358,774, OSI-774, Tarceva

    Given orally

  • Stereotactic RadiosurgeryRadiation

    Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy

    Patients undergo surgery after radiation therapy

  • TemozolomideDrug

    Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831

    Given orally

Study groups in NCT00096265
Study groupRoleWhat they receive
Arm IActive comparatorPatients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Stereotactic Radiosurgery
Arm IIExperimentalPatients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Stereotactic Radiosurgery; Drug: Temozolomide
Arm IIIExperimentalPatients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Drug: Erlotinib Hydrochloride; Radiation: Stereotactic Radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.

    Measured: From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Secondary outcomes (6)

  1. Rate of CNS Progression (One Year)

    CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression). For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression. This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes. For greater than 1 cm lesions, the definition uses a 25% rule for change. Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk.

    Measured: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

  2. Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument

    Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition. The QALY model is QALY(h,y) where h is a health state and y is the years of life. Higher quality-adjusted life year values represent a better outcome. A patient's health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival. The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state).

    Measured: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

  3. Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months

    The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL. A change of 5 points will be considered a minimal clinically meaningful change. Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased.

    Measured: From randomization to three months.

  4. Change in Performance Status at Six Months

    Compared between two treatment arms using a two-group chi-squared test. Zubrod score will be collected at baseline and follow-up. The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death. Change from baseline is calculated as 6-month value - baseline value. Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months.

    Measured: From randomization to six months.

  5. Change in Steroid Dependence at Six Months

    Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, >4 to ≤ 8 mg, >8 to ≤12 mg, and >12 mg. Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories.

    Measured: From randomization to six months.

  6. Cause of Death (Neurologic vs Other)

    Patients were considered to have died neurologic deaths (coded as "Brain Metastases") if they had stable systemic disease and progressive neurologic disease consisting of expanding intracranial masses, CNS hemorrhages, hydrocephalus resulting in herniation or fulminant meningeal carcinomatosis.

    Measured: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2004 (estimated)
  2. Study start6 Oct 2004
  3. Primary completion14 Jun 2011
  4. Study completion1 Apr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096265
Sponsor's protocol ID
NCI-2009-00720
Other IDs
NCI-2009-00720, CDR0000389490, RTOG 0320, RTOG 0320, RTOG-0320, U10CA021661
Status last verified
Feb 2018
First submitted
9 Nov 2004
Last updated
9 Mar 2018

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Erlotinib Hydrochloride and Stereotactic Radiosurgery in people with Metastatic Malignant Neoplasm in the Brain and Recurrent Non-Small Cell Lung Carcinoma, run by National Cancer Institute (NCI) at 83 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 57 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.

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