Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02) (LU02)
2017年8月10日 更新者：University of Florida
A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer
The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer.
The dose you receive to the tumor will be higher than the standard dose.
This may be able to increase the control of the tumor.
Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard.
This may be able to reduce the frequency and severity of the usual radiation side effects.
調査の概要
状態
終了しました
条件
研究の種類
介入
入学 (実際)
15
段階
- 適用できない
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
-
-
Florida
-
Jacksonville、Florida、アメリカ、32206
- University of Florida Proton Therapy Institute
-
-
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:
- Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
- Patient must be at least 18 years old at the time of consent.
- Stage III A or III B disease.
- Patients must be able to start study treatment within 6 weeks of study enrollment.
- Induction chemotherapy is allowed.
- Marginally resectable or unresectable at presentation.
- If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.
Exclusion Criteria:
- Evidence of distant metastasis.
- Prior thoracic radiotherapy.
- Any history of allergic reaction to taxanes.
- Prior tumor resection. Candidate for upfront curative surgery.
- Pleural effusion visible on chest x-ray or the scout view of the CT chest.
- Unintentional weight loss within the month prior to diagnosis ≥ 10%.
- Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
- The presence of PET positive contralateral hilar disease.
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：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：PET positive nodal disease measuring 15 mm or greater
Proton radiation with concomitant chemotherapy
|
Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy.
他の名前：
|
|
実験的：PET positive nodal disease measuring less than 15 mm
Proton radiation
|
Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy.
他の名前：
|
|
実験的：Patients considered resectable
Proton radiation plus surgery
|
Proton radiation at 2 cobalt gray per fraction.
Re-evaluation performed between days 18-22 of treatment.
If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed.
他の名前：
|
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 |
|---|---|
|
Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
時間枠：Six months after end of radiation therapy
|
Six months after end of radiation therapy
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Patients With Disease Control
時間枠：Following treatment every 6 months for 2 years, then annually for 4 years.
|
Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD).
As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."),
as accurate.
|
Following treatment every 6 months for 2 years, then annually for 4 years.
|
|
Percentage of Patients Alive at 5 Years
時間枠：Five years following radiation treatment
|
Five years following radiation treatment
|
|
|
Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy
時間枠：Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually
|
Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually
|
|
|
Correlation of Functional CT-PET Imaging With Treatment Outcomes
時間枠：Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years
|
Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years
|
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。
スポンサー
捜査官
- 主任研究者：Bradford S Hoppe, MD, MPH、University of Florida Proton Therapy Institute
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
- Chapet O, Kong FM, Quint LE, Chang AC, Ten Haken RK, Eisbruch A, Hayman JA. CT-based definition of thoracic lymph node stations: an atlas from the University of Michigan. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):170-8. doi: 10.1016/j.ijrobp.2004.12.060.
- Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.
- Belani CP, Choy H, Bonomi P, Scott C, Travis P, Haluschak J, Curran WJ Jr. Combined chemoradiotherapy regimens of paclitaxel and carboplatin for locally advanced non-small-cell lung cancer: a randomized phase II locally advanced multi-modality protocol. J Clin Oncol. 2005 Sep 1;23(25):5883-91. doi: 10.1200/JCO.2005.55.405. Epub 2005 Aug 8. Erratum In: J Clin Oncol. 2006 Apr 20;24(12):1966.
- Perez CA, Pajak TF, Rubin P, Simpson JR, Mohiuddin M, Brady LW, Perez-Tamayo R, Rotman M. Long-term observations of the patterns of failure in patients with unresectable non-oat cell carcinoma of the lung treated with definitive radiotherapy. Report by the Radiation Therapy Oncology Group. Cancer. 1987 Jun 1;59(11):1874-81. doi: 10.1002/1097-0142(19870601)59:113.0.co;2-z.
- Lee HK, Vaporciyan AA, Cox JD, Tucker SL, Putnam JB Jr, Ajani JA, Liao Z, Swisher SG, Roth JA, Smythe WR, Walsh GL, Mohan R, Liu HH, Mooring D, Komaki R. Postoperative pulmonary complications after preoperative chemoradiation for esophageal carcinoma: correlation with pulmonary dose-volume histogram parameters. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1317-22. doi: 10.1016/s0360-3016(03)01373-7.
- Graham MV, Purdy JA, Emami B, Harms W, Bosch W, Lockett MA, Perez CA. Clinical dose-volume histogram analysis for pneumonitis after 3D treatment for non-small cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):323-9. doi: 10.1016/s0360-3016(99)00183-2.
- Cancer Facts and Figures 2008 - American Cancer Society http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf
- Delaney, Kooy editors: Proton and Charged particle Radiotherapy; LWW, 2008
- Chang JY, Zhang X, Wang X, Kang Y, Riley B, Bilton S, Mohan R, Komaki R, Cox JD. Significant reduction of normal tissue dose by proton radiotherapy compared with three-dimensional conformal or intensity-modulated radiation therapy in Stage I or Stage III non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1087-96. doi: 10.1016/j.ijrobp.2006.01.052. Epub 2006 May 6.
- Auberger T, Seydl K, Futschek T, Sztankay A, Sweeney RA, Lukas P. Photons or protons: precision radiotherapy of lung cancer. Strahlenther Onkol. 2007 Dec;183 Spec No 2:3-6. doi: 10.1007/s00066-007-2002-9. No abstract available.
- Nichols RC, Henderson RH, Huh SN, Flampouri S, Cury JD, Pham DC, D'Agostino HJ, Louis D, Li Z, Mendenhall NP. Proton Radiotherapy Offers Reduced Bone Marrow and Normal Lung Exposure for Patients Receiving Dose Escalated Radiotherapy with Concomitant Chemotherapy for Regionally Advanced Non-Small Cell Lung Cancer. Presented at the LALCa 2008 - 3rd Latin American Conference on Lung Cancer - Tercera Conferencia Latinoamericana sobre Cancer Pulmonar - Vina del Mar, Chile - October 9 and 10, 2008
- Komaki R, Sejpal S, Wei X, et al. Reduction of Bone Marrow Suppression for Patients with Stage III NSCLC Treated by Proton and Chemotherapy Compared with IMRT and Chemotherapy. Proceedings of the PTCOG 47, May 19-24, 2008.
- Curran W, Scott C, Langer C, et al. Long term benefit is observed in a phase III comparison of sequential vs. concurrent chemo-radiation for patients with unresectable NSCLC: RTOG 9410. Proc Am Soc Clin Oncol 2003;61(abstr).
- Rosenzweig KE, Sim SE, Mychalczak B, Braban LE, Schindelheim R, Leibel SA. Elective nodal irradiation in the treatment of non-small-cell lung cancer with three-dimensional conformal radiation therapy. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):681-5. doi: 10.1016/s0360-3016(01)01482-1.
- Martel MK, et al. Incidental doses to clinically negative nodes from conformal treatment fields for non-small cell lung cancer. Int J Rad Oncol Biol Phys. 45(3 (supplement)): 244, 1999.
- Nichols RC, Huh SN, Hoppe BS, Henderson RH, Li Z, Mendenhall NP. Protons Safely Allow Coverage of High Risk Nodes for Patients with Regionally Advanced NSCLC, University of Florida Proton Therapy Institute. Submitted for consideration. American Radium Society, 2009.
- Rosenman JG, Halle JS, Socinski MA, Deschesne K, Moore DT, Johnson H, Fraser R, Morris DE. High-dose conformal radiotherapy for treatment of stage IIIA/IIIB non-small-cell lung cancer: technical issues and results of a phase I/II trial. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):348-56. doi: 10.1016/s0360-3016(02)02958-9.
- Fletcher GH. Clinical dose-response curves of human malignant epithelial tumours. Br J Radiol. 1973 Jan;46(541):1-12. doi: 10.1259/0007-1285-46-541-1. No abstract available.
- Albain KS, Swann RS, Rusch VR, et al. Phase III study of concurrent chemotherapy and radiotherapy (CT/RT) vs. CT/RT followed by surgical resection for stage IIIA (pN2) non-small cell lung cancer (NSCLC): Outcomes update of North American Intergroup 0139 (RTOG 9309). Proc Am Soc Clin Oncol, abstract 7014, 2005.
- Lau D, Leigh B, Gandara D, Edelman M, Morgan R, Israel V, Lara P, Wilder R, Ryu J, Doroshow J. Twice-weekly paclitaxel and weekly carboplatin with concurrent thoracic radiation followed by carboplatin/paclitaxel consolidation for stage III non-small-cell lung cancer: a California Cancer Consortium phase II trial. J Clin Oncol. 2001 Jan 15;19(2):442-7. doi: 10.1200/JCO.2001.19.2.442.
- Choy H, Akerley W, Safran H, Graziano S, Chung C, Williams T, Cole B, Kennedy T. Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer. J Clin Oncol. 1998 Oct;16(10):3316-22. doi: 10.1200/JCO.1998.16.10.3316.
- Vokes E, Herndon J, Turrisi A. Induction chemotherapy followed by concomitant chemoradiotherapy (CT/XRT) versus CT/XRT alone for regionally advanced unresectable non-small cell lung cancer (NSCLC): Initial analysis of a randomized phase III trial. Pro Amer Soc Clin Oncol. 23(616A), 2004.
- Bradley J, et al. Phase I results of RTOG 0117; A phase I/II dose intensification study using 3DCRTand concurrent chemotherapy for patients with inoperable non-small cell lung cancer. Pro Amer Soc Clin Oncol. 24: p. 7063A, 2005.
- Blackstock A. Cancer and Leukemia Group B: Induction plus concurrent chemotherapy with high dose (74 Gy) 3 dimensional (3-D) thoracic radiotherapy in stage III non-small cell lung cancer. Preliminary report of CALGB 30105. Pro Amer Soc Clin Oncol. 24(1): 7042, 2006.
- Roth JA, Atkinson EN, Fossella F, Komaki R, Bernadette Ryan M, Putnam JB Jr, Lee JS, Dhingra H, De Caro L, Chasen M, Hong WK. Long-term follow-up of patients enrolled in a randomized trial comparing perioperative chemotherapy and surgery with surgery alone in resectable stage IIIA non-small-cell lung cancer. Lung Cancer. 1998 Jul;21(1):1-6. doi: 10.1016/s0169-5002(98)00046-4.
- Chvetsov AV, Palta JJ, Nagata Y. Time-dependent cell disintegration kinetics in lung tumors after irradiation. Phys Med Biol. 2008 May 7;53(9):2413-23. doi: 10.1088/0031-9155/53/9/013. Epub 2008 Apr 17.
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
2009年6月1日
一次修了 (実際)
2014年10月1日
研究の完了 (実際)
2014年10月1日
試験登録日
最初に提出
2009年4月13日
QC基準を満たした最初の提出物
2009年4月13日
最初の投稿 (見積もり)
2009年4月15日
学習記録の更新
投稿された最後の更新 (実際)
2017年9月11日
QC基準を満たした最後の更新が送信されました
2017年8月10日
最終確認日
2017年8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。
非小細胞肺がんの臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ