Radiation Therapy in Treating Patients With Liver Metastases
A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases.
Secondary
- Determine the failure patterns and survival of patients treated with this regimen.
- Correlate dose-volume characteristics with possible toxic effects of this regimen in these patients.
- Determine the local control rate within irradiated fields in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study.
Patients undergo highly conformal radiotherapy (HCR) to the liver once daily, 5 days a week, for 2 weeks.
Cohorts of 6 patients receive escalating doses of HCR until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Histologically confirmed non-lymphoma liver metastases
- New radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer AND a previously negative CT scan, MRI, or PET/CT scan of the liver
- No more than 5 measurable lesions by contrast-enhanced liver CT scan, MRI, or PET/CT scan
- Liver metastases ≤ 8 cm
- Medically unfit for surgery OR lesions are surgically unresectable
- All intrahepatic disease must be encompassed within the study radiation field
- Extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting
- At least 1,000 cc of normal liver
- No clinical ascites
- No CNS metastases
PATIENT CHARACTERISTICS:
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,800/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
- No active hepatitis
- No clinically significant liver failure
- No underlying cirrhosis
Renal
- Not specified
Cardiovascular
- No congestive heart failure requiring hospitalization within the past 6 months
- No unstable angina pectoris requiring hospitalization within the past 6 months
- No transmural myocardial infarction within the past 6 months
Pulmonary
- No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis
- No acute bacterial or fungal infection requiring IV antibiotics
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- No anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy)
Radiotherapy
- No prior radiotherapy to the region of study
- No concurrent intensity-modulated radiotherapy
Surgery
- Prior liver resection or ablative therapy allowed
Other
- No concurrent warfarin or IV heparin
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Radiation therapy dose level II: 4.0 Gy/fx
Radiation therapy dose level II: 4.0 Gy/fraction
|
|
|
他の：Radiation therapy dose level III: 4.5 Gy/fx
Radiation therapy dose level III: 4.5 Gy/fraction
|
|
|
他の：Radiation therapy dose level IV: 5.0 Gy/fx
Radiation therapy dose level IV: 5.0 Gy/fraction
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
To determine the maximally tolerated dose
時間枠：From start of treatment to 90 days
|
From start of treatment to 90 days
|
協力者と研究者
捜査官
- 主任研究者：Alan W. Katz, MD、James P. Wilmot Cancer Center
- スタディチェア：Laura A. Dawson, MD、Princess Margaret Hospital, Canada
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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