Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumors Metastatic to Brain |
Radiation: radiation therapy Drug: thalidomide Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases |
- Overall survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Cumulative incidence model will be used to analyze the data.
- Cause of death distribution [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Quality of life as measured by the Spitzer Quality of Life Index (SQLI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life as measured by the SQLI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 332 |
| Study Start Date: | March 2002 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (radiation therapy)
Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
|
Radiation: radiation therapy
Undergo conventional radiation therapy
Other Names:
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
|
Experimental: Arm II (radiation therapy, thalidomide)
Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.
|
Radiation: radiation therapy
Undergo conventional radiation therapy
Other Names:
Drug: thalidomide
Given orally
Other Names:
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
Detailed Description:
OBJECTIVES:
I. 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.
V. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Contacts and Locations| United States, Pennsylvania | |
| Radiation Therapy Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| Principal Investigator: | Jonathan Knisely | Radiation Therapy Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033254 History of Changes |
| Other Study ID Numbers: | NCI-2012-02461, RTOG-BR-0118, CDR0000069268, RTOG-DEV-1006, U10CA021661 |
| Study First Received: | April 9, 2002 |
| Last Updated: | June 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013