Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury
Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury
調査の概要
詳細な説明
We propose a prospective study to investigate the combinational effect of radiotherapeutic dosimetric parameters [mean lung dose and percentage of lung volume receiving at least XGy (Vx)] and biological parameters [interleukin-1α(IL1α),interleukin-1β(IL1β),interleukin-6(IL6),interleukin-7(IL7),transforming growth factor beta (TGFB)] and manganese superoxide dismutase(MnSOD) in predicting radiation pneumonitis, fibrosis, and radiation esophageal injury. Eligibility included pathological or cytological proven thoracic cancer,ECOG performance status [PS] 0-2, no prior thoracic RT or chemotherapy,no distant metastasis and signed informed consent prior to study entry.
Basic pre-treatment information will be collected, which included ECOG PS, UICC/AJCC stage,primary lesion site, history of smoking/coexisting lung disease/surgical resection, and pulmonary function test of FEV1/VC/DLCO. Computed tomography [CT] of the whole lung in treatment position. Blood test of IL1α,IL1β,IL6,IL7,TGFB and MnSOD by ELISA will be done before and weekly during RT. RT must be given by photon energies >=6MV. Radiation lung and esophageal injury will be assessed according to common toxicity criteria adverse effect version3.0 [CTCAE-3.0] during RT and in every follow up visits. Genomic DNA is obtained from the blood drawn during RT. Chi-square test, T test, analysis of variance, logistic regression, and proportional hazard ratio method will be used to investigate whether the parameter(s) can be effective in predicting radiation related sequelae.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Shanghai、中国、200032
- Fudan University, Cancer Hospital, Department of Radiation Oncology
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Non-pregnant adults (18<= age <= 75 y/o)
- Chinese ethnicity
- Pathological or cytological proven thoracic neoplasms (of note,sputum cytology alone is not acceptable.Cytological specimens obtained by brushing,washing and needle aspiration of a defined lesion are acceptable)
- Initially treated
- No distant metastasis
- ECOG PS 0-2 (Karnofsky>60%)
- Understand and willing to sign the consent
Normal organ and marrow function as defined below:
- Leukocytes >=3,000/µL
- Haemoglobin >=9 g/dL (prior to transfusions)
- Absolute neutrophil count >=1,500/µL
- Platelets >=100,000/µL
- Total bilirubin < 1.5 x upper limit of normal
- AST (SGOT)/ALT (SGPT) ≤2.5 X institutional upper limit of normal
- Creatinine <=2.5 mg/dl.
Exclusion Criteria:
- Prior thoracic radiotherapy
- Distant metastasis
- Allergic reactions attributed to compounds of similar chemical or biologic composition to platinum-based drugs.
- Pre-existed non-oncological pulmonary or esophageal disease that may put the patient at high risk of severe toxicities.
- Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirement
- pregnancy or lactating
- Receiving other investigational agents or devices
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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1
There is only one group in this study.
The patients of this group will go through procedures as follow: basic pre-treatment information collected,treatment include platinum-based chemotherapy and 3-D conformal radiotherapy, blood test during RT 6am every Monday and follow-up visits with treatment-induced injury assessed.
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Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies >=6MV.
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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Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]
時間枠：from the begining of treatment to the end of follow-up
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from the begining of treatment to the end of follow-up
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協力者と研究者
捜査官
- 主任研究者：Min Fan, MD、Fudan University Cancer Hospital, Department of Radiation Oncology
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 (予想される)
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
本研究に関する用語
キーワード
その他の研究ID番号
- FDCA002
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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Thoracic 3-D Conformal Radiotherapyの臨床試験
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Centre Hospitalier Universitaire, Amiens完了
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City of Hope Medical CenterNational Cancer Institute (NCI)引きこもった
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University of ChicagoNational Institutes of Health (NIH); University of Houstonまだ募集していません自家脂肪移植