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Non-small Cell Lung Cancer (NSCLC)STEREONCT01300299

STEREOtactic Radiation and Chemotherapy in Lung Cancer (STEREO)

A study testing Stereotactic Body Radiation Therapy in people with Non-small Cell Lung Cancer (NSCLC), run by University of Louisville at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
Stereotactic Body Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2011to Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: 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).

Read the 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).

Keywords
lung cancer, radiation, stereotactic
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body Radiation TherapyRadiation

    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 groups in NCT01300299
Study groupRoleWhat they receive
All subjectsExperimentalSubjects will receive chemotherapy after stereotactic body radiation therapy.
Receives: Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To measure the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC)

    Measured: 3 years after subject enrollment

Secondary outcomes (4)

  1. Survival rate, specifically disease-free survival (DFS) and overall survival (OS), measured by follow-up visits and tests

    Measured: 3 years after subject enrollment

  2. safety of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) measured by adverse events

    Measured: 3 years after subject enrollment

  3. quality of life (QOL) measured by subject questionnaires

    Measured: 3 years after subject enrollment

  4. Measurement of biological and clinical markers for toxicity, DFS, and OS

    Measured: 3 years after subject enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Why it stopped: Unable to enroll

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01300299
Sponsor's protocol ID
BCC-LUN-10-STEREO
Acronym
STEREO
Status last verified
Mar 2018
First submitted
17 Feb 2011
Last updated
5 Mar 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Body Radiation Therapy in people with Non-small Cell Lung Cancer (NSCLC), run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01300299.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.

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