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Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

2019年9月4日 更新者：Radiation Therapy Oncology Group

A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery.

PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

OBJECTIVES:

  • Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose radiotherapy followed by surgical resection for patients found to be resectable and consolidative chemotherapy comprising paclitaxel and carboplatin.
  • Determine the rate of complete pathological response in patients treated with this regimen.
  • Determine the feasibility of surgical resection after neoadjuvant induction chemoradiotherapy in these patients.
  • Determine disease-free and overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

研究の種類

介入

入学 (実際)

60

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

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85013
        • Arizona Oncology Services Foundation
      • Scottsdale、Arizona、アメリカ、85260
        • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
    • California
      • Los Angeles、California、アメリカ、90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Florida
      • Jacksonville、Florida、アメリカ、32224
        • Mayo Clinic - Jacksonville
      • Tallahassee、Florida、アメリカ、32308
        • Tallahassee Memorial Hospital
    • Illinois
      • Springfield、Illinois、アメリカ、62702
        • Cancer Institute at St. John's Hospital
    • Maryland
      • Baltimore、Maryland、アメリカ、21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor、Michigan、アメリカ、48106
        • CCOP - Michigan Cancer Research Consortium
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis、Missouri、アメリカ、63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • Nebraska
      • Omaha、Nebraska、アメリカ、68114
        • Methodist Estabrook Cancer Center
    • New Jersey
      • Camden、New Jersey、アメリカ、08103
        • Cancer Institute of New Jersey at Cooper University Hospital - Camden
      • Voorhees、New Jersey、アメリカ、08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • North Carolina
      • Greenville、North Carolina、アメリカ、27835-6028
        • Leo W. Jenkins Cancer Center at ECU Medical School
    • Pennsylvania
      • Bethlehem、Pennsylvania、アメリカ、18015
        • St. Luke's Cancer Network at St. Luke's Hospital
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Tennessee
      • Kingsport、Tennessee、アメリカ、37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • West Virginia
      • Wheeling、West Virginia、アメリカ、26003
        • Schiffler Cancer Center at Wheeling Hospital
    • Wisconsin
      • Green Bay、Wisconsin、アメリカ、54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Milwaukee、Wisconsin、アメリカ、53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee、Wisconsin、アメリカ、53295
        • Veterans Affairs Medical Center - Milwaukee

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:

  1. Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present);
  2. Disease must be measurable;
  3. Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease;
  4. Patients ≥ 18 years of age;
  5. Life expectancy ≥ 6 months;
  6. Zubrod performance status 0- 1 (See Appendix II);
  7. Pretreatment laboratory values must be as follows: White blood cell count (WBC) count: ≥ 3,000/mm^3; Absolute granulocyte count: ≥ 1,500/mm^3; Platelets: ≥ 100,000/mm3; Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine: ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL
  8. Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0 then V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report.
  9. Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy;
  10. Women of childbearing potential and male participants must practice an effective method of contraception during the study;

  11. Pretreatment evaluations required for eligibility include:

    • A complete medical history & physical examination to include Zubrod performance status, neurologic assessment, recent weight loss, usual weight, concurrent non-malignant disease and therapy;
    • Location, type, and size of measurable lesion must be recorded prior to treatment;
    • Complete blood count (CBC) with differential, platelet count, electrolytes, and Mg++ within 14 days prior to study entry;
    • Twelve-channel serum multiple analysis (SMA-12): Total protein, Albumin, Calcium, Glucose, Blood urea nitrogen (BUN), Creatinine, Alkaline Phosphatase, Lactate dehydrogenase (LDH), Total Bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) within 14 days prior to study entry;
    • Women of childbearing potential must have a negative pre-study serum or urine pregnancy test within 14 days prior to study entry.
    • Mediastinoscopy, thoracoscopy, Chamberlain procedure, or bronchoscopy with transbronchial needle aspirate to evaluate the extent of lymph node involvement;
    • Computed tomography (CT) scan of the chest to include liver, and adrenal glands within 6 weeks prior to study entry;
    • Positron emission tomography (PET) scan within 8 weeks prior to study entry. Any suspicious areas outside of the local regional disease requires documented evaluation of these findings to exclude metastatic disease;
    • CT scan or magnetic resonance imaging (MRI) of the brain within 6 weeks prior to study entry;
    • Electrocardiogram (EKG) and pulmonary function tests including forced vital capacity (FVC), FEV-1, and diffusing capacity of carbon monoxide (DLCO), within 8 weeks prior to study entry; V/Q scan, if applicable, within 8 weeks prior to study entry.
  12. Patients must sign a study-specific informed consent prior to study entry.

Exclusion Criteria:

  1. Small cell lung cancer; distant metastatic disease;
  2. Evidence of clinical or radiographic supraclavicular lymph node involvement;
  3. Bronchioalveolar carcinoma with lobar or multilobar involvement;
  4. Unintentional weight loss > 5% within 6 months prior to study entry, or Zubrod performance status 2 or greater;
  5. Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal cord dose to 48 Gy;
  6. Patients with malignant pleural effusion;
  7. Clinically evident superior vena cava syndrome;
  8. Prior systemic chemotherapy or radiation therapy to the thorax;
  9. Patients with known hypersensitivity to Cremophor EL;
  10. Patients receiving other investigational therapy;
  11. Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks to the participant and to the embryo or fetus;
  12. Patients with an active serious infection or other serious underlying medical condition that would impair their ability to complete protocol treatment;
  13. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.

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：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
実験的：Chemoradiation, Surgery, Chemotherapy
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
放射線：放射線治療
薬：Induction Carboplatin
薬：Induction Paclitaxel
手順：切除
薬：Consolidation Carboplatin
薬：Consolidation Paclitaxel

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
メジャーの説明
時間枠
Mediastinal Nodal Clearance Rate
時間枠：At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.
If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.
At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.

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 Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy
時間枠：At time of surgery (16-18 weeks)
Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen.
At time of surgery (16-18 weeks)
Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery
時間枠：From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration)
The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death.
From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration)
Percentage of Patients Able to Undergo Surgical Resection
時間枠：At time of surgery (16-18 weeks)
At time of surgery (16-18 weeks)
Distribution of R0, R1, and R2 Resections After Chemotherapy
時間枠：At time of surgery (16-18 weeks)
An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection.
At time of surgery (16-18 weeks)
Overall Survival at Two Years
時間枠：From registration to two years
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
From registration to two years
Progression-free Survival at Two Years
時間枠：From registration to two years
Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method.
From registration to two years
Distribution of Highest Grade Adverse Event
時間枠：From start of treatment to end of follow-up, a maximum of 64.3 months
The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented.
From start of treatment to end of follow-up, a maximum of 64.3 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。

スポンサー

Radiation Therapy Oncology Group

協力者

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Mohan Suntharalingam, MD、University of Maryland Greenebaum Cancer Center

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

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

2004年9月1日

一次修了 (実際)

2012年4月1日

研究の完了 (実際)

2016年5月16日

試験登録日

最初に提出

2004年11月9日

QC基準を満たした最初の提出物

2004年11月8日

最初の投稿 (見積もり)

2004年11月9日

学習記録の更新

投稿された最後の更新 (実際)

2019年9月18日

QC基準を満たした最後の更新が送信されました

2019年9月4日

最終確認日

2019年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RTOG-0229
  • CDR0000389508

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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