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STEREOtactic Radiation and Chemotherapy in Lung Cancer (STEREO) (STEREO)

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ClinicalTrials.gov Identifier: NCT01300299
Recruitment Status : Withdrawn (Unable to enroll)
First Posted : February 21, 2011
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Goetz Kloecker, University of Louisville

Tracking Information
First Submitted Date  ICMJE February 17, 2011
First Posted Date  ICMJE February 21, 2011
Last Update Posted Date March 5, 2018
Study Start Date  ICMJE February 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
To measure the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) [ Time Frame: 3 years after subject enrollment ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
To measure the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) [ Time Frame: 2 years after subject enrollment ]
Change History Complete list of historical versions of study NCT01300299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
  • Survival rate, specifically disease-free survival (DFS) and overall survival (OS), measured by follow-up visits and tests [ Time Frame: 3 years after subject enrollment ]
  • safety of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) measured by adverse events [ Time Frame: 3 years after subject enrollment ]
  • quality of life (QOL) measured by subject questionnaires [ Time Frame: 3 years after subject enrollment ]
  • Measurement of biological and clinical markers for toxicity, DFS, and OS [ Time Frame: 3 years after subject enrollment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
  • Survival rate, specifically disease-free survival (DFS) and overall survival (OS), measured by follow-up visits and tests [ Time Frame: 2 years after subject enrollment ]
  • safety of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) measured by adverse events [ Time Frame: 2 years after subject enrollment ]
  • quality of life (QOL) measured by subject questionnaires [ Time Frame: 2 years after subject enrollment ]
  • Measurement of biological and clinical markers for toxicity, DFS, and OS [ Time Frame: 2 years after subject enrollment ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE STEREOtactic Radiation and Chemotherapy in Lung Cancer (STEREO)
Official Title  ICMJE STEREOtactic Radiation and Adjuvant Chemotherapy in Lung Cancer (STEREO)
Brief Summary This trial will test the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC).
Detailed Description

This study evaluates the effect of adjuvant chemotherapy in patients who received treatment with stereotactic radiation for early stage lung cancer and who are at high risk for microscopic metastatic disease.

Chemotherapy in the form of cisplatin/docetaxel or cisplatin/pemetrexed will be administered approximately six weeks after Stereotactic Body Radiation Therapy (SBRT). Patients will then undergo follow up clinical evaluation and imaging to evaluate treatment response and for surveillance.

A patient population of 65 patients will be required. Enrollment in this protocol is planned by multi center involvement in the state of Kentucky as part of the Kentucky Trial Network (KTN).

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer (NSCLC)
Intervention  ICMJE Radiation: Stereotactic Body Radiation Therapy
12 Gray (Gy) x 4 fractions (48 Gy) will be delivered to peripherally located tumors (> 2 cm in all directions around the proximal bronchial tree and centrally located tumors (within <2 centimeters (cm) of proximal bronchial tree). Treatment should be given on consecutive days. There will be 4 or 5 treatments.
Study Arms Experimental: All subjects
Subjects will receive chemotherapy after stereotactic body radiation therapy.
Intervention: Radiation: Stereotactic Body Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 4, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2011)
65
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Histologically diagnosed non-small cell lung cancer(NSCLC, cT1-T3 (<= 5cm) (AJCC 7ed). The following histologies are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine, or non-small cell carcinoma not otherwise specified; bronchioloalveolar cell carcinoma is a subtype of NSCLC but will be excluded from this study because assessment of multifocal disease spread through the airways is difficult.
  • Required CT of the chest and abdomen with contrast unless medically contraindicated (evaluating both lungs, mediastinum, liver, and adrenals) and Whole Body Positron Emission Tomography (PET) for staging. An integrated PET/Computed Tomography (CT) will meet the CT and PET requirements for staging. Images must be read by a trained radiologist and performed 8 weeks prior to initiation of treatment. PET imaging must allow adequate visualization of the primary tumor, draining lymphatics in hilar and mediastinum, adrenals, and skeleton.

Note: Per Radiation Therapy Oncology Group (RTOG) 0915 inclusion criteria, patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer.

  • Deemed medically inoperable by an experienced thoracic cancer clinician for a standard lobectomy and lymph node sampling/dissection. Inoperability may be defined utilizing a number of criteria. These include any of the following:
  • Pretreatment Forced Expiratory Volume (FEV1) < 40% predicted
  • Postoperative FEV1 < 30% predicted
  • Severely reduced diffusion capacity
  • Baseline hypoxemia and/or hypercapnia
  • Exercise oxygen consumption < 50% predicted
  • Severe pulmonary hypertension
  • Diabetes mellitus with severe end organ damage
  • Severe cerebral, cardiac, or peripheral vascular disease
  • Decline surgery after evaluation by a thoracic surgeon

Required laboratory values within 2 weeks of chemotherapy initiation

  • Absolute neutrophil count (ANC) ≥ 1500 mm3
  • Platelets ≥ 100,000/mm3
  • Total Bilirubin ≤ 1.5 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT)- aspartate aminotransferase (AST) < 5 x upper limit of normal (ULN}
  • Serum glutamic pyruvic transaminase (SGPT)- alanine transaminase(ALT) < 5 x upper limit of normal (ULN)
  • Serum Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
  • For patients assigned to pemetrexed/Cisplatin therapy calculated Creatinine Clearance (CrCl) must be obtained within 2 weeks of randomization and calculated CrCl must be > 45mL/min using the standard Cockcroft and Gault formula

Exclusion Criteria:

  • Primary lesion size not within the acceptable criteria
  • Evidence of regional metastases or distant metastases following appropriate staging
  • Previous radiation to the chest
  • Chemotherapy within the previous five years
  • Previous surgery for this particular lung tumor
  • Plans for concomitant chemotherapy with radiation
  • Active systemic or pulmonary infection
  • Pregnant or lactating females
  • Synchronous primary malignancy or prior malignancy in the past 2 years except for invasive malignancy that has been treated definitively and the patient remains disease free for > 3 years with life expectancy > 3 years. Previous skin cancers and carcinoma in situ treated definitively are acceptable.
  • Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology
  • Bronchioloalveolar cell carcinoma is excluded because assessment of multifocal disease spread through the airways is difficult
  • Receipt of any other investigational agents or participation in any other investigational drug study within 4 weeks preceding initiation of study treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01300299
Other Study ID Numbers  ICMJE BCC-LUN-10-STEREO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Goetz Kloecker, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE James Graham Brown Cancer Center
Investigators  ICMJE
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center
PRS Account University of Louisville
Verification Date March 2018

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