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TerminatedNCT00020839Updated Sep 24, 2012

Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain

A Phase 3 interventional study of temozolomide and radiation therapy in Melanoma (Skin) and Metastatic Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Terminated at 33 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-24.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment

Why this study was terminated
low accrual
Phase
Phase 3
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of temozolomide with or without radiotherapy in terms of overall survival in patients with stage IV melanoma with asymptomatic brain metastases.
  • Compare the time to appearance of neurological symptoms in patients treated with these regimens.
  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the quality of life and quality-adjusted survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to LDH levels (less than 225 U/L vs 225 U/L or more), concurrent metastases (visceral vs soft tissue), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral temozolomide once daily on days 1-5. Treatment continues every 4 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive temozolomide as in arm I and whole brain radiotherapy on days 8-12 and 15-19 during the first course of chemotherapy.

Quality of life is assessed before beginning each course and then every 4 weeks after completion of study drug.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 2 years.

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Conditions studied

  • Melanoma (Skin)
  • Metastatic Cancer

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Keywords

  • stage IV melanoma
  • recurrent melanoma
  • tumors metastatic to brain
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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 23 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable metastatic melanoma

    • Must have asymptomatic brain metastasis that is not amenable to surgery or stereotactic radiosurgery (gamma knife, Linac)
    • Must have concurrent visceral/soft tissue metastases
  • At least 1 site of measurable disease (not necessarily the brain metastasis)
  • Documented evidence of disease progression defined by 1 of the following conditions:

    • More than 25% increase in the size of at least 1 measurable lesion
    • Appearance of a new lesion
    • A significant increase in the size of nonmeasurable disease
  • No neurological symptoms, including signs of elevated intracranial pressure

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 3 times ULN
  • Alkaline phosphatase less than 3 times ULN

Renal:

  • Urea less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN

Other:

  • No frequent vomiting or medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake
  • No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • No uncontrolled infection
  • HIV negative
  • No AIDS-related illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior cytokine via isolated limb perfusion for local-regional melanoma allowed
  • No other prior cytokine for metastatic melanoma
  • No concurrent colony-stimulating factors, including epoetin alfa or filgrastim (G-CSF)
  • No other concurrent immunologic or biologic therapy

Chemotherapy:

  • Prior chemotherapy via isolated limb perfusion for local-regional melanoma allowed
  • No other prior chemotherapy for metastatic melanoma
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids allowed during radiotherapy (arm II only)
  • No concurrent hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • No other concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from the effects of any prior major surgery

Other:

  • No other concurrent investigational drugs
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Enrollment
23 participants (actual)

Interventions

  • Drugtemozolomide
  • Radiationradiation therapy
06

Study locations

33 sites
  • Krankenhaus der Elisabethinen
    Linz, 4020, Austria
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • Hopital Universitaire Erasme
    Brussels, 1070, Belgium
  • Universitair Ziekenhuis Antwerpen
    Edegem, B-2650, Belgium
  • Clinique Notre Dame de Grace
    Gosselies, 6041, Belgium
  • Onkologicka Klinka A Onkologicka Lab
    Prague, 128 08, Czech Republic
  • CHU de Bordeaux - Hopital Pellegrin
    Bordeaux, 33076, France
  • CHU Ambroise Pare
    Boulogne Billancourt, F-92104, France
  • Centre Hospital Regional Universitaire de Limoges
    Limoges, 87042, France
  • Hopital L'Archet - 2
    Nice, F-06202, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Institut Gustave Roussy
    Villejuif, F-94805, France
  • Universitaetsklinikum Benjamin Franklin
    Berlin, D-12200, Germany
  • Federal Armed Forces Hospital of Ulm - Department of Dermatology
    Blaustein, D-89134, Germany
  • Universitaets - Augenklinik - Erlangen
    Erlangen, D-91054, Germany
  • Georg August Universitaet
    Goettingen, D-37075, Germany
  • Haematologisch-Onkologische Praxis Altona
    Hamburg, D-22765, Germany
  • III Medizinische Klinik Mannheim
    Mannheim, D-68305, Germany
  • Eberhard Karls Universitaet
    Tuebingen, D-72076, Germany
  • Universitaet Wuerzburg/Hautkrankheiten
    Wuerzburg, D-97080, Germany
  • Istituto Nazionale per la Ricerca sul Cancro
    Genoa (Genova), 16132, Italy
  • University Medical Center Nijmegen
    Nijmegen, NL-6500 HB, Netherlands
  • Erasmus University Medical Center
    Rotterdam, 3075 EA, Netherlands
  • Norwegian Radium Hospital
    Oslo, N-0310, Norway
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
    Lisbon, 1093, Portugal
  • UniversitaetsSpital
    Zurich, CH-8091, Switzerland
  • Addenbrooke's NHS Trust
    Cambridge, England CB2 2QQ, United Kingdom
  • St. James's Hospital
    Leeds, England LS9 7TF, United Kingdom
  • Royal Marsden NHS Trust
    London, England SW3 6JJ, United Kingdom
  • Christie Hospital N.H.S. Trust
    Manchester, England M20 9BX, United Kingdom
  • Weston Park Hospital
    Manchester, England M20 9BX, United Kingdom
  • Clatterbridge Centre for Oncology NHS Trust
    Merseyside, England CH63 4JY, United Kingdom
  • Southend NHS Trust Hospital
    Westcliff-On-Sea, England SS0 0RY, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00020839
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Apr 2001
Primary completion
May 2003
Last update
Sep 24, 2012

Study contacts

Juergen C. Becker, MD, PhD
study chair · Universitaets-Hautklinik Wuerzburg
View the source record on ClinicalTrials.gov ↗

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