Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19103
- Radiation Therapy Oncology Group
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Arm I (radiation therapy)
Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
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보조 연구
다른 이름들:
Undergo conventional radiation therapy
다른 이름들:
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실험적: 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.
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보조 연구
다른 이름들:
구두로 주어진
다른 이름들:
Undergo conventional radiation therapy
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival
기간: Up to 6 years
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The log-rank statistic will be used.
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Up to 6 years
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Time to tumor progression
기간: Date of randomization to documentation of progression, assessed up to 6 years
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Cumulative incidence model will be used to analyze the data.
A multivariate Cox model analysis will be performed.
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Date of randomization to documentation of progression, assessed up to 6 years
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Time to neuro-cognitive progression as assessed by the Mini Mental State Exam
기간: Up to 6 years
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Cumulative incidence model will be used to analyze the data.
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Up to 6 years
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Cause of death distribution
기간: Up to 6 years
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Up to 6 years
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Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
기간: Up to 6 years
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Up to 6 years
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Quality of life as measured by the Spitzer Quality of Life Index (SQLI)
기간: 6 months
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6 months
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Quality of life as measured by the SQLI
기간: 12 months
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12 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Jonathan Knisely, Radiation Therapy Oncology Group
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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