A Study Comparing Chemotherapy Dosing Based on Either Standard Body Surface Area or Lean Body Mass in Patients With Advanced Lung Cancer
2014年9月26日 更新者：AHS Cancer Control Alberta
A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy
Cancer patients are highly variable in their body composition, specifically in the proportion of fat and muscle.
Some patients tend to gain fat and lose muscle (or lean body mass) at the same time.
These patients can develop severe muscle wasting, termed sarcopenia.
Patients with sarcopenia have more severe treatment related toxicity requiring delays, dose reductions and stopping of treatment, and have reduced survival.
One potential explanation for this is that patients with sarcopenia have a reduced volume of lean body mass into which chemotherapy drugs are distributed, resulting in a higher concentration and greater toxicity.
This study will randomize lung cancer patients to either the standard dosing strategy based on body surface area or experimental, personalized dosing based on lean body mass.
Based on retrospective findings in this patient population, the investigators expect to find that severe toxicity will be reduced for sarcopenic patients on the personalized dosing arm based on lean body mass.
調査の概要
状態
わからない
条件
詳細な説明
Retrospective findings of NSCLC patients treated with a cisplatin based chemotherapy regimen show that although all were given cisplatin at the standard rate of 75 mg/m2 according to lean body mass, when this was expressed in relation to individual lean body mass, there was a high degree of variation.
Incidence of dose limiting toxicity was 41% in patients whose dose was within + 25% of the median value.
However, sarcopenic patients received on average a 35% higher dose and 80% of these patients experienced severe toxicity requiring dose reduction or termination of therapy, a clinically unacceptable level.
The relatively muscular subset of patients with higher lean body mass had a reduced level of severe toxicity compared to those at the median dose.
These findings have led to the design of a study with the goal of reducing high levels of toxicity in sarcopenic patients.
If the expected level of dose limiting toxicity in sarcopenic patients is 80% based on the standard method of dosing, this could be expected to be reduced to the median value of 41% dose limiting toxicity by the administration of cisplatin scaled to individual lean body mass.
Hypothesis: Levels of severe toxicity in sarcopenic patients may be reduced to clinically acceptable levels by cisplatin dosing scaled to 3.1 mg/kg lean body mass compared with standard dosing of 75 mg/m2 based on body surface area.
研究の種類
介入
入学 (予想される)
144
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alberta
-
Edmonton、Alberta、カナダ、T6G 1Z2
- 募集
- Cross Cancer Institute
-
主任研究者：
- Michael B Sawyer, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Recommendation from treating oncologist to receive a cisplatin based chemotherapy regimen, specifically either cisplatin/vinorelbine or cisplatin/gemcitabine
- > or = 18 years of age
- Histologically proven diagnosis of non-small cell lung cancer, Stage IIIB or IV
- Adequate renal function: creatinine < 1.5 mg/dL or < 132 µmol/L and creatinine clearance of > 45 mL/min using the Cockcroft-Gault formula
- Adequate hepatic function: bilirubin < 1.5 mg/dL or < 25 µmol/L and AST and ALT < 2 times upper limit of normal, unless there is evidence of liver metastases, in which case < 5 times upper limit of normal
- Adequate hematological function: absolute neutrophil count (ANC) > 1.5 x 109/L and platelets > 100 x 109/L and hemoglobin > 100 g/L
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Negative serum pregnancy test for women of childbearing potential. Women and men of child bearing potential must use effective contraception defined as the simultaneous use of two reliable methods unless abstinence is the chosen method.
- Life expectancy of > 4 months in the opinion of the treating oncologist
- Prior radiotherapy is allowed (unless > 25% of bone marrow stores) if this radiation was > 4 weeks before study entry and patient has fully recovered from toxicity of this treatment
- Willingness to comply with the study protocol
- Ability to give written informed consent with the understanding that it may be withdrawn at any time without prejudice
Exclusion Criteria:
- Pregnant or lactating women
- Brain metastases (a CT or MRI is not required to rule out brain metastases unless there is clinical suspicion)
- Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix, in situ ductal breast cancer, non-melanoma skin cancer or low grade bladder cancer
- Patients who have had major surgery within three weeks of enrollment without a full recovery
- Prior treatment with any anticancer therapy
- Patients who have tested positive for HIV
- Any significant medical or psychiatric condition that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Body Surface Area Dosing
Standard dosing arm based on body surface area
|
Cisplatin dosing calculated at the rate of 75 mg/m2
|
|
実験的：Lean Body Mass Dosing
Experimental dosing arm based on individual lean body mass
|
Cisplatin dosing calculated at the rate of 3.10 mg/kg lean body mass
|
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 |
|---|---|
|
Dose limiting toxicity rates
時間枠：Assessed weekly until patients come off study (an expected average of 9 weeks)
|
Assessed weekly until patients come off study (an expected average of 9 weeks)
|
|
Number of Cycles completed
時間枠：Assessed weekly until patients come off study (an expected average of 9 weeks)
|
Assessed weekly until patients come off study (an expected average of 9 weeks)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Survival
時間枠：Assessed every 60 days from the date of removal from the trial (an expected average of 9 months)
|
If a patient has deceased, the date of death is recorded.
If a patient is alive, the status is checked again in another 60 days.
This is carried out through health records and not through direct contact with the patient.
|
Assessed every 60 days from the date of removal from the trial (an expected average of 9 months)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Michael B Sawyer, MD、Medical Oncologist, Cross Cancer Institute
- スタディチェア：Vickie Baracos, PhD、Grant Holder, Department of Oncology, University of Alberta
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.
- Tan BH, Birdsell LA, Martin L, Baracos VE, Fearon KC. Sarcopenia in an overweight or obese patient is an adverse prognostic factor in pancreatic cancer. Clin Cancer Res. 2009 Nov 15;15(22):6973-9. doi: 10.1158/1078-0432.CCR-09-1525. Epub 2009 Nov 3.
- Prado CM, Baracos VE, McCargar LJ, Mourtzakis M, Mulder KE, Reiman T, Butts CA, Scarfe AG, Sawyer MB. Body composition as an independent determinant of 5-fluorouracil-based chemotherapy toxicity. Clin Cancer Res. 2007 Jun 1;13(11):3264-8. doi: 10.1158/1078-0432.CCR-06-3067.
- Prado CM, Baracos VE, McCargar LJ, Reiman T, Mourtzakis M, Tonkin K, Mackey JR, Koski S, Pituskin E, Sawyer MB. Sarcopenia as a determinant of chemotherapy toxicity and time to tumor progression in metastatic breast cancer patients receiving capecitabine treatment. Clin Cancer Res. 2009 Apr 15;15(8):2920-6. doi: 10.1158/1078-0432.CCR-08-2242. Epub 2009 Apr 7.
- Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年7月1日
一次修了 (予想される)
2015年9月1日
研究の完了 (予想される)
2015年9月1日
試験登録日
最初に提出
2012年4月26日
QC基準を満たした最初の提出物
2012年6月18日
最初の投稿 (見積もり)
2012年6月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年9月30日
QC基準を満たした最後の更新が送信されました
2014年9月26日
最終確認日
2014年9月1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。