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

4 de septiembre de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Radiación: Radioterapia
Droga: Induction Carboplatin
Droga: Induction Paclitaxel
Procedimiento: Resección
Droga: Consolidation Carboplatin
Droga: Consolidation Paclitaxel

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mediastinal Nodal Clearance Rate
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At time of surgery (16-18 weeks)
At time of surgery (16-18 weeks)
Distribution of R0, R1, and R2 Resections After Chemotherapy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Radiation Therapy Oncology Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Mohan Suntharalingam, MD, University of Maryland Greenebaum Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2004

Finalización primaria (Actual)

1 de abril de 2012

Finalización del estudio (Actual)

16 de mayo de 2016

Fechas de registro del estudio

Enviado por primera vez

9 de noviembre de 2004

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2004

Publicado por primera vez (Estimar)

9 de noviembre de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

4 de septiembre de 2019

Última verificación

1 de septiembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RTOG-0229
  • CDR0000389508

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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