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

March 1, 2018 updated by: Goetz Kloecker, University of Louisville

STEREOtactic Radiation and Adjuvant Chemotherapy in Lung Cancer (STEREO)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years after subject enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
3 years after subject enrollment
quality of life (QOL) measured by subject questionnaires
Time Frame: 3 years after subject enrollment
3 years after subject enrollment
Measurement of biological and clinical markers for toxicity, DFS, and OS
Time Frame: 3 years after subject enrollment
3 years after subject enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Goetz H Kloecker, MD, James Graham Brown Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCC-LUN-10-STEREO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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