STEREOtactic Radiation and Chemotherapy in Lung Cancer (STEREO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by James Graham Brown Cancer Center
Sponsor:
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01300299
First received: February 17, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

This trial will test the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC).


Condition Intervention Phase
Non-small Cell Lung Cancer (NSCLC)
Radiation: Stereotactic Body Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STEREOtactic Radiation and Adjuvant Chemotherapy in Lung Cancer (STEREO)

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • quality of life (QOL) measured by subject questionnaires [ Time Frame: 3 years after subject enrollment ] [ Designated as safety issue: No ]
  • Measurement of biological and clinical markers for toxicity, DFS, and OS [ Time Frame: 3 years after subject enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All subjects
Subjects will receive chemotherapy after stereotactic body radiation therapy.
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300299

Contacts
Contact: Goetz H. Kloecker, MD 502-562-4358 ghkloe01@louisville.edu
Contact: Shaio Y Woo, MD 502-561-2700 sywoo001@gwise.louisville.edu

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Goetz H Kloecker, MD         
Sponsors and Collaborators
James Graham Brown Cancer Center
Investigators
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01300299     History of Changes
Other Study ID Numbers: BCC-LUN-10-STEREO
Study First Received: February 17, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
lung cancer
radiation
stereotactic

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014