Melanoma (Skin)Phase 3NCT00020839
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 study testing temozolomide and radiation therapy in people with Melanoma (Skin) and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Metastatic Cancer
- What is being tested?
- temozolomide and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 33 sitesin 11 countries
- Study dates
- Apr 2001to May 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
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
Trial locations and contacts
33 sites in 11 countries.
33 sites in 11 countries
Germany8 sites
Universitaetsklinikum Benjamin Franklin
Berlin, D-12200
Federal Armed Forces Hospital of Ulm - Department of Dermatology
Blaustein, D-89134
Universitaets - Augenklinik - Erlangen
Erlangen, D-91054
Georg August Universitaet
Göttingen, D-37075
Haematologisch-Onkologische Praxis Altona
Hamburg, D-22765
III Medizinische Klinik Mannheim
Mannheim, D-68305
Eberhard Karls Universitaet
Tübingen, D-72076
Universitaet Wuerzburg/Hautkrankheiten
Würzburg, D-97080
United Kingdom7 sites
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
St. James's Hospital
Leeds, England, LS9 7TF
Royal Marsden NHS Trust
London, England, SW3 6JJ
Christie Hospital N.H.S. Trust
Manchester, England, M20 9BX
Weston Park Hospital
Manchester, England, M20 9BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, CH63 4JY
Southend NHS Trust Hospital
Westcliff-on-Sea, England, SS0 0RY
France6 sites
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, 33076
CHU Ambroise Pare
Boulogne-Billancourt, F-92104
Centre Hospital Regional Universitaire de Limoges
Limoges, 87042
Hopital L'Archet - 2
Nice, F-06202
Centre Eugene Marquis
Rennes, 35042
Institut Gustave Roussy
Villejuif, F-94805
Belgium4 sites
Institut Jules Bordet
Brussels, 1000
Hopital Universitaire Erasme
Brussels, 1070
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Clinique Notre Dame de Grace
Gosselies, 6041
Netherlands2 sites
University Medical Center Nijmegen
Nijmegen, NL-6500 HB
Erasmus University Medical Center
Rotterdam, 3075 EA
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
Lisbon, 1093
About this study
Official title: Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases
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.
- Conditions
- Melanoma (Skin), Metastatic Cancer
- Being tested
- temozolomide, radiation therapy
- Keywords
- stage IV melanoma, recurrent melanoma, tumors metastatic to brain
- Medical subject headings
- Melanoma, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2001
- Primary completionMay 2003
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Juergen C. Becker, MD, PhD, Study chair, Universitaets-Hautklinik Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020839
- Sponsor's protocol ID
- EORTC-18981
- Other IDs
- EORTC-18981
- Status last verified
- Sep 2012
- First submitted
- 11 Jul 2001
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases
- ClinicalTrials.gov ID
- NCT00020839
- Acronym / sponsor ID
- EORTC-18981
- Conditions
- Melanoma (Skin), Metastatic Cancer
- Keywords
- stage IV melanoma, recurrent melanoma, tumors metastatic to brain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 23 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 2001
- Primary completion
- May 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temozolomide | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juergen C. Becker, MD, PhD study chair
Universitaets-Hautklinik Wuerzburg
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing temozolomide and radiation therapy in people with Melanoma (Skin) and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, United Kingdom, France, Belgium, Netherlands and 6 more countries. 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?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
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.
Where can I read the original study information?
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 24 Sep 2012.