Concurrent Chemoradiotherapy (CCRT) With Paclitaxel Plus Cisplatin in LA Non-small-cell Lung Cancer (NSCLC)
Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer
調査の概要
詳細な説明
Lung cancer is a major cause of cancer death in Taiwan and throughout the world in both developed and developing countries. More than 75% of NSCLC patients are inoperable because of either distantly metastatic disease or disease confined to one hemithorax with one or more criteria of unresectability at the time of presentation. The prognosis of such inoperable metastatic patients is poor.
The benefit of adding chemotherapy to radiation therapy for stage III disease of NSCLC is well-established. The largest of the prospective trials was sponsored by the Radiation Therapy Oncology Group (RTOG), ECOG, and the Southwest Oncology Group (SWOG), and allocated 490 patients to receive 2 months of cisplatin + vinblastine chemotherapy followed by 60 Gy of radiation at 2 Gy per fraction; or one of two radiation-alone arms. Overall survival was statistically superior for the patients receiving chemotherapy and radiation versus the other two arms of the study (13.2 months vs 12 months, vs 11.4 months, respectively; p=0.04).
Administration of chemotherapy concurrently with radiation therapy theoretically improves local control by sensitizing the tumor to radiation, while simultaneously treating systemic disease, albeit at the expense of greater local toxicity. Two large phase III studies suggest improvement in both local control and survival with concurrent chemoradiotherapy as compared with sequential chemotherapy followed by radiation for patients with stage III NSCLC. Although rates of nonhematologic toxicity were higher on the concurrent arms, median survival time trended toward superiority in the concomitant chemotherapy plus daily radiation arm compared with the sequential arm.
One source of debate is whether the addition of induction or consolidation chemotherapy adds anything to concomitant chemoradiotherapy, with numerous intergroup trials underway. CALGB has completed a randomized phase II study of two cycles of induction chemotherapy followed by two additional cycles of the same drugs with concomitant radiotherapy. The three treatment arms included four cycles of cisplatin (80 mg/m2) combined with either gemcitabine, paclitaxel, or vinorelbine. Radiotherapy was completed during the last two cycles to a total of 66 Gy. Response rates were similar, and median survival for all patients was 17 months with no clearly superior arm evident in this randomized phase II trial.
We proposed this clinical trial to evaluate the efficacy and toxicity profile of combination chemotherapy with paclitaxel and cisplatin in previously untreated, stage IIIa/IIIb NSCLC patients who received 1 cycle of induction chemotherapy, followed by concurrent chemoradiotherapy, with 2 cycles of consolidation chemotherapy.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Taipei City、台湾
- Taipei VGH
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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
Inclusion Criteria:
- Histologic or cytological diagnosis of inoperable locally advanced (stage III) NSCLC.
- No prior chemotherapy, immunotherapy, or radiotherapy.
- Performance status of 0 to 2 on the Zubrod scale.
- Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by computerized tomography (CT) scan, magnetic resonance imaging (MRI), or chest x-ray.
- Estimated life expectancy of at least 12 weeks.
- Patient compliance and geographic proximity that allow adequate follow-up.
- Adequate bone marrow reserve: white blood cell (WBC) count *4,000/mm3, platelets >100,000/mm3, and hemoglobin *10 g/dL.
- Informed consent from patient.
- Males or females 18 years of age or older.
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial.
Exclusion Criteria:
- Active infection (at the discretion of the investigator).
- Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 3 times normal (ALT and AST may be elevated to 5 times normal in patients with known metastatic disease in the liver).
- Inadequate renal function (creatinine >2.0 mg/dL).
- Pregnancy or not using appropriate birth control during the study.
- Breast feeding.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Use of any investigational agent in the month before enrollment into the study.
- Patients with leukemia and/or a secondary primary carcinoma except for patients who have had curative therapy to basal cell carcinoma.
- Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as previously noted for radiation.
- Active cardiac disease requiring therapy for failure, angina, and/or arrhythmias; infarctions within the preceding six months (exception: any patient whose cardiac failure is compensated on medications).
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:なし
- 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 |
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他の:1
Induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
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Induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
他の名前:
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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 |
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To determine the efficacy of this treatment modality in patients with inoperable stage III NSCLC
時間枠:one year
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one year
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二次結果の測定
結果測定 |
時間枠 |
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To determine the toxicity profiles of this treatment modality in patients with inoperable stage III NSCLC
時間枠:one year
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one year
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協力者と研究者
捜査官
- 主任研究者:Yuh-Min Chen, MD, PhD.、Chest Department, Taipei VGH
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。
非小細胞肺がんの臨床試験
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