Tumors Metastatic to BrainPhase 3NCT00033254
Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
A Phase 3 study testing radiation therapy, thalidomide and quality-of-life assessment in people with Tumors Metastatic to Brain, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors Metastatic to Brain
- What is being tested?
- radiation therapy, thalidomide and quality-of-life assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to May 2006
- 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
Who may be able to join
- Histologically confirmed extracranial primary malignancy
- Multiple brain metastases
- At least 1 measurable brain metastasis by MRI
- More than 4.0 cm
- Located in midbrain or brainstem (radiosurgery ineligible)
- Performance status - Zubrod 0-1
Show all 30Show fewer
- At least 8 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 11 g/dL*
- Hematocrit at least 35%*
- Bilirubin no greater than 1.5 mg/dL
- ALT no greater than 2 times normal
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
- No history of deep venous thrombosis
- No sensory neuropathy grade 2 or greater
- No known AIDS
- No other major medical illness or psychiatric impairments that would preclude study therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier method of contraception during and for at least 4 weeks after study
- No prior thalidomide
- More than 2 weeks since prior chemotherapy
- Concurrent chemotherapy allowed if more than 6 weeks past study entry (allowed during first 6 weeks of study if disease progression occurs)
- See Disease Characteristics
- No prior radiotherapy to the head or neck
- No prior radiosurgery
- Prior resection of brain metastases allowed
- No concurrent anticoagulant therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.
Read the detailed description
OBJECTIVES:
- Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide.
II. Compare the time to tumor progression in patients treated with these regimens.
III. Compare the time to neuro-cognitive progression in patients treated with these regimens.
IV. Compare the cause of death distribution in patients treated with these regimens.
- Compare the frequency of toxic effects of these regimens in these patients. VI. Evaluate and compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks. Arm II: Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.
Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, and then every 2 months for 1 year.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.
- Conditions
- Tumors Metastatic to Brain
- Being tested
- radiation therapy, thalidomide, quality-of-life assessment
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo conventional radiation therapy
thalidomideDrug
Also called Kevadon, Synovir, THAL, Thalomid
Given orally
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (radiation therapy) | Active comparator | Patients undergo radiotherapy once daily 5 days a week for 3 weeks. Receives: Radiation: radiation therapy; Procedure: quality-of-life assessment |
| Arm II (radiation therapy, thalidomide) | Experimental | Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily. Receives: Radiation: radiation therapy; Drug: thalidomide; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The log-rank statistic will be used.
Measured: Up to 6 years
Time to tumor progression
Cumulative incidence model will be used to analyze the data. A multivariate Cox model analysis will be performed.
Measured: Date of randomization to documentation of progression, assessed up to 6 years
Time to neuro-cognitive progression as assessed by the Mini Mental State Exam
Cumulative incidence model will be used to analyze the data.
Measured: Up to 6 years
Secondary outcomes (4)
Cause of death distribution
Measured: Up to 6 years
Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Measured: Up to 6 years
Quality of life as measured by the Spitzer Quality of Life Index (SQLI)
Measured: 6 months
Quality of life as measured by the SQLI
Measured: 12 months
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 startMar 2002
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors Metastatic to BrainStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Jonathan Knisely, Principal investigator, Radiation Therapy Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033254
- Sponsor's protocol ID
- NCI-2012-02461
- Other IDs
- RTOG-BR-0118, CDR0000069268, U10CA021661
- Status last verified
- Oct 2020
- First submitted
- 9 Apr 2002
- Last updated
- 30 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
- ClinicalTrials.gov ID
- NCT00033254
- Acronym / sponsor ID
- NCI-2012-02461
- Conditions
- Tumors Metastatic to Brain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- NRG Oncology
- Study start
- Mar 2002
- Primary completion
- May 2006 (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.
Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.
Detailed description
OBJECTIVES:
- Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide.
II. Compare the time to tumor progression in patients treated with these regimens.
III. Compare the time to neuro-cognitive progression in patients treated with these regimens.
IV. Compare the cause of death distribution in patients treated with these regimens.
- Compare the frequency of toxic effects of these regimens in these patients. VI. Evaluate and compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks. Arm II: Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.
Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, and then every 2 months for 1 year.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (radiation therapy) | Active comparator | Radiation: radiation therapy, Procedure: quality-of-life assessmentPatients undergo radiotherapy once daily 5 days a week for 3 weeks. |
| Arm II (radiation therapy, thalidomide) | Experimental | Radiation: radiation therapy, Drug: thalidomide, Procedure: quality-of-life assessmentPatients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Histologically confirmed extracranial primary malignancy
- Multiple brain metastases
- At least 1 measurable brain metastasis by MRI
- Performance status - Zubrod 0-1
- At least 8 weeks
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo conventional radiation therapy | Radiation | Arm I (radiation therapy), Arm II (radiation therapy, thalidomide) |
| thalidomideAlso: Kevadon, Synovir, THAL, ThalomidGiven orally | Drug | Arm II (radiation therapy, thalidomide) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (radiation therapy), Arm II (radiation therapy, thalidomide) |
Primary outcome
Overall survival
Time frame: Up to 6 years
The log-rank statistic will be used.
Time to tumor progression
Time frame: Date of randomization to documentation of progression, assessed up to 6 years
Cumulative incidence model will be used to analyze the data. A multivariate Cox model analysis will be performed.
Time to neuro-cognitive progression as assessed by the Mini Mental State Exam
Time frame: Up to 6 years
Cumulative incidence model will be used to analyze the data.
4 secondary outcomes
Cause of death distribution
Time frame: Up to 6 years
Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Time frame: Up to 6 years
Quality of life as measured by the Spitzer Quality of Life Index (SQLI)
Time frame: 6 months
Quality of life as measured by the SQLI
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
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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.
Jonathan Knisely principal investigator
Radiation Therapy Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy, thalidomide and quality-of-life assessment in people with Tumors Metastatic to Brain, run by National Cancer Institute (NCI) at 1 site in United States.
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 30 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: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Up to 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 30 Oct 2020.