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Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00979212
First received: September 16, 2009
Last updated: June 30, 2016
Last verified: June 2016

September 16, 2009
June 30, 2016
February 2011
December 2015   (final data collection date for primary outcome measure)
Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab. [ Time Frame: From date of randomization to time of protocol surgery, approximately 12 weeks. ] [ Designated as safety issue: No ]
The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.
Mediastinal nodal clearance after completion of induction chemoradiotherapy with or without cetuximab [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00979212 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study ] [ Designated as safety issue: No ]
    Survival time was calculated from the date of randomization to the date of death from any cause or the date of last follow-up. The Kaplan-Meier method was used to estimate the overall survival rates. One-year survival rates were estimated, not compared.
  • Patterns of First Failure [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ] [ Designated as safety issue: No ]
    The first failure site will be tabulated, not compared.
  • Acute and Late Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ] [ Designated as safety issue: Yes ]
  • Surgical Morbidities in Patients With Resectable Disease at Reassessment [ Time Frame: From date of surgery to 30 days following surgery. ] [ Designated as safety issue: Yes ]
    A surgical morbidity is any toxicity occurring within 30 days of protocol surgery, as evaluated using CTCAE v4.0. Rates of grade 3 and higher surgical morbidity were calculated; the rates across arms were not compared.
  • Ability of FDG-PET/CT Scan Data to Predict Outcome [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ] [ Designated as safety issue: No ]
  • Overall Survival [ Designated as safety issue: No ]
  • Patterns of First Failure [ Designated as safety issue: No ]
  • Acute and late adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Surgical Morbidities in Patients With Resectable Disease at Reassessment [ Designated as safety issue: No ]
  • Correlation between pre- and post-treatment biomarkers (including EGFR and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival) [ Designated as safety issue: No ]
  • Prognostic value of plasma osteopontin and microRNA for overall survival [ Designated as safety issue: No ]
  • Ability of FDG-PET scan data to predict outcome [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab (IND #110152) Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy (CT), such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy (RT) uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without panitumumab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see how well they work when given with or without panitumumab in treating patients with stage IIIA non-small cell lung cancer.

OBJECTIVES:

Primary

  • Determine the mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab in patients with stage IIIA non-small cell lung cancer.

Secondary

  • Assess overall survival of these patients.
  • Evaluate patterns of first failure in these patients.
  • Determine the acute and late adverse events associated with these regimens.
  • Assess surgical morbidities in patients with resectable disease at reassessment.
  • Determine the correlation between pre- and post-treatment biomarkers (including epidermal growth factor receptor (EGFR) and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival).
  • Evaluate the prognostic value of plasma osteopontin and microRNA for overall survival.
  • Assess the ability of FDG-PET/CT scan re-staging to predict outcome.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo intensity-modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
  • Arm II: Patients receive induction therapy comprising panitumumab IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 8, 15, 22, 29, and 36. Patients also undergo IMRT or 3D-CRT once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
  • In both arms, patients with resectable disease and no disease progression may proceed to surgery (thoracotomy, lobectomy, or pneumonectomy) approximately 4-6 weeks after completion of induction therapy. After surgery, patients proceed to consolidation therapy.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: panitumumab
    Induction: 2.5 mg/kg, IV, days 1, 8, 15, 22, 29, 36 of radiation therapy before administration of chemotherapy and radiation therapy.
    Other Name: Vectibix
  • Drug: carboplatin
    Induction: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. Consolidation, 6-12 weeks following surgery, AUC=6, IV, days 1 and 22.
    Other Name: Paraplatin
  • Drug: paclitaxel
    Induction: 50 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. Consolidation, 6-12 weeks following surgery, 200 mg/m2, IV, days 1 and 22.
    Other Names:
    • Taxol
    • Abraxane
  • Procedure: surgery
    A lobectomy or pneumonectomy performed 4-6 weeks after completion of induction chemoradiation
    Other Names:
    • lobectomy
    • pneumonectomy
  • Active Comparator: Induction CT+RT
    Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Procedure: surgery
  • Experimental: Induction CT+RT+Panitumumab
    Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
    Interventions:
    • Drug: panitumumab
    • Drug: carboplatin
    • Drug: paclitaxel
    • Procedure: surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
71
Not Provided
December 2015   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed* non-small cell lung cancer (NSCLC), including any of the following histologies:

    • Adenocarcinoma
    • Adenosquamous
    • Large cell carcinoma
    • Squamous cell carcinoma
    • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
    • NSCLC not otherwise specified NOTE: *Documentation of NSCLC may originate from the mediastinal node biopsy or aspiration
  • Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar nodes (N1)

    • N2 nodes must be separate from primary tumor by either CT scan or surgical exploration
    • Maximum nodal diameter of involved N2 nodes cannot exceed 3.0 cm
    • N2 status must be pathologically confirmed to be positive by one of the following methods*:

      • Mediastinoscopy
      • Mediastinotomy (Chamberlain procedure)
      • Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)
      • Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)
      • Thoracotomy
      • Video-assisted thoracoscopy
      • Transbronchial needle biopsy by Wang technique (TBNA)
      • Fine-needle aspiration under CT guidance NOTE: *PET positivity in the ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal status
    • Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied unless all of the following are true:

      • Tumor is left sided
      • Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
      • Nodes visible in the anterior/posterior (level 5) region on CT scan
      • Distinct primary tumor separate from nodes visible on CT scan
      • Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor
    • If lymph nodes in the contralateral mediastinum and neck are visible on contrast CT scan of the chest and are > 1.0 cm in short axis or if contralateral involvement is suggested by PET scan, then the nodes must be confirmed to be negative
  • Measurable disease as determined by contrast-enhanced CT scan

    • Primary lung tumor distinct from mediastinal lymph nodes
  • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable M1a disease):

    • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
    • Exudative pleural effusions are excluded, regardless of cytology;
    • Effusions that are minimal (i.e. not visible under ultrasound guidance) that are too small to safely tap are eligible.
  • No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless proven to be benign by fine-needle aspiration or biopsy
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
  • Creatinine clearance ≥ 60 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Serum albumin > 3.0 g/dL
  • Serum magnesium normal (supplementation allowed)
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of treatment
  • Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1 ≥ 0.8 L
  • Diffusion capacity ≥ 50% predicted
  • No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:

    • Current uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (<50%)
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or that would preclude study therapy within the past 4 weeks
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • AIDS or known HIV positivity
  • No unintentional weight loss ≥ 5% of body weight within the past 6 months
  • No prior severe infusion reaction to a monoclonal antibody
  • No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy or biological therapy (including erlotinib hydrochloride or similar agents) for the study cancer

    • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No prior therapy that specifically and directly targets the EGFR pathway
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00979212
RTOG-0839, CDR0000654690, NCI-2011-01970
Yes
Not Provided
Not Provided
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Martin J. Edelman, MD University of New Maryland
Radiation Therapy Oncology Group
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP