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Status:

TERMINATED

Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

SWOG Cancer Research Network

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiati...

Detailed Description

OBJECTIVES: Primary * Compare overall survival of patients with newly diagnosed favorable prognosis stage IIIA non-small cell lung cancer treated with neoadjuvant cisplatin and docetaxel with vs wit...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)\*, including any of the following cellular types:
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Large cell carcinoma
  • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
  • NSCLC not otherwise specified NOTE: \*Diagnosed within the past 3 months; diagnosis by mediastinal nodal biopsy or needle aspiration allowed provided a distinct lung primary (separate from the nodes) is clearly evident on CT scan
  • Stage IIIA disease
  • T1-T3 disease
  • If pleural effusion is present, must meet ≥ 1 of the following criteria to exclude T4 disease:
  • Pleural effusion cytologically negative by thoracentesis
  • Documented absence of pleural metastases and pleural effusion cytologically negative by thoracoscopy (for patients with pleural effusion on CT scan \[but not on chest x-ray\] that is deemed too small to tap safely under either CT scan or ultrasound guidance)
  • Confirmed positive ipsilateral mediastinal lymph node(s) (N2 disease)\*\*, with or without positive ipsilateral hilar nodes, by mediastinoscopy, mediastinotomy, endoscopic ultrasound-guided transesophageal biopsy, thoracotomy, video-assisted thoracoscopy, Wang needles, or fine needle aspiration under bronchoscopic or CT guidance
  • N2 nodes must be separate from primary tumor by CT scan or surgical exploration AND maximum diameter ≤ 3.0 cm
  • Mediastinoscopy OR other means of mediastinal lymph node biopsy required (regardless of the primary tumor site) for patients with subcarinal lymphadenopathy by size criteria or by positron emission tomography (PET) scan
  • If the lymph nodes in the contralateral mediastinum and neck are visible by contrast CT scan of the chest AND are ≥ 1.0 cm OR if contralateral involvement is suggested by PET scan, lymph nodes must be confirmed negative by one of the above diagnostic procedures AND N3 status must be confirmed negative by histology or cytology
  • No palpable lymph nodes in the supraclavicular areas or higher in the neck unless proven benign by excisional biopsy
  • A nodal biopsy or needle aspiration may be omitted provided all of the following criteria are true:
  • Paralyzed left true vocal cord by bronchoscopy or indirect laryngoscopy
  • Nodes visible in the aortopulmonary window (level 5) region on CT scan
  • Distinct primary tumor (separate from the nodes) is visible by CT scan
  • No evidence of subcarinal nodal involvement by CT scan NOTE: \*\*PET scan positivity is not sufficient to establish N2 nodal status
  • Measurable disease by chest x-ray and/or contrast-enhanced CT scan
  • Candidate for surgery
  • Resectable disease
  • No distant metastases, including other ipsilateral or contralateral parenchymal lesions or liver or adrenal metastases, by history or physical examination, fludeoxyglucose F 18 PET scan, MRI or CT scan of the brain, chest x-ray and/or CT scan of the lungs and upper abdomen
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,800/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Hepatic
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No hepatic insufficiency resulting in clinical jaundice or coagulation defects
  • Renal
  • Creatinine clearance ≥ 60 mL/min
  • Cardiovascular
  • No unstable angina or congestive heart failure requiring hospitalization within the past 6 months
  • No transmural myocardial infarction within the past 6 months
  • Pulmonary
  • FEV\_1 ≥ 2.0 L OR
  • Predicted post-resection FEV\_1 ≥ 0.8 L
  • DLCO ≥ 50% of predicted
  • No chronic obstructive pulmonary disease exacerbation
  • No other respiratory illness requiring hospitalization or that would preclude study therapy
  • Immunologic
  • No AIDS
  • No prior allergic reaction to the study drugs
  • No history of severe hypersensitivity to other drugs formulated with polysorbate 80
  • No acute bacterial or fungal infection requiring IV antibiotics
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No unintentional weight loss \> 5% of body weight within the past 6 months
  • No pre-existing peripheral neuropathy ≥ grade 2
  • 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 other severe active comorbidity
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior biological agent for this cancer
  • No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim during study induction therapy (for patients randomized to the chemoradiotherapy arm)
  • Chemotherapy
  • No prior systemic chemotherapy for this cancer
  • Prior chemotherapy for a different cancer allowed
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
  • No routine post-operative radiotherapy
  • No concurrent intensity modulated radiotherapy
  • Surgery
  • See Disease Characteristics
  • Other
  • No prior gefitinib for this cancer
  • No concurrent amifostine

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    19 Patients enrolled

    Trial Details

    Trial ID

    NCT00113386

    Start Date

    April 1 2005

    Last Update

    June 28 2013

    Active Locations (76)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 19 (76 locations)

    1

    Cancer Center at Providence Alaska Medical Center

    Anchorage, Alaska, United States, 99519-6604

    2

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    3

    Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, United States, 94524-4110

    4

    Moores UCSD Cancer Center

    La Jolla, California, United States, 92093-0658