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Lung CancerPhase 3NCT00107172

Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

A Phase 3 study testing surgery and brachytherapy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
surgery and brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
38 sitesin 2 countries
Study dates
Jul 2005to 15 Feb 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)
  • Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC)
  • Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
  • Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2
  • Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:
Show all 24Show fewer
  • Major criteria
  • Forced expiratory volume in 1 second (FEV1) =< 50% predicted
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted
  • Minor criteria
  • Age >= 75
  • FEV1 51-60% predicted
  • DLCO 51-60% predicted
  • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
  • Poor left ventricular function (defined as an ejection fraction of 40% or less)
  • Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%
  • Partial pressure of carbon dioxide (pCO2) > 45 mm Hg
  • Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
  • Patient must not have had previous intra-thoracic radiation therapy
  • Women of child-bearing potential must have negative serum or urine pregnancy test
  • No prior invasive malignancy, unless disease-free for >= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)
  • PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)
  • Patient must have biopsy-proven NSCLC
  • Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on positron emission tomography [PET] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)

Who cannot join

None listed.

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States37 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Methodist Hospital

    Houston, Texas, 77030

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • U.T. Medical Center Cancer Institute

    Knoxville, Tennessee, 37920-6999

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Jameson Memorial Hospital - North Campus

    New Castle, Pennsylvania, 16105

  • South Nassau Communities Hospital

    Oceanside, New York, 11572

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Valley Hospital - Ridgewood

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Simmons Cooper Cancer Institute

    Springfield, Illinois, 62794-9677

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Cancer Institute at St. Joseph Medical Center

    Towson, Maryland, 21204

Other trials in United States

Canada1 site

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

Other trials in Canada

About this study

Official title: A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller

This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum [N1 nodes], or progression at the staple line after treatment effects such as scarring have subsided).

SECONDARY OBJECTIVES:

  1. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence.
  2. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.

ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin.

After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.

Conditions
Lung Cancer
Being tested
surgery, brachytherapy
Keywords
stage I non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • surgeryProcedure or surgery

  • brachytherapyRadiation

Study groups in NCT00107172
Study groupRoleWhat they receive
Arm IActive comparatorPatients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Receives: Procedure: surgery
Arm IIExperimentalPatients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Receives: Procedure: surgery; Radiation: brachytherapy

What is being measured

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

  1. Time to Local Recurrence

    Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.

    Measured: Up to 3 years

Secondary outcomes (11)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to 5 years

  2. Number of Participants Reported Local Recurrence at 3 Years

    Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.

    Measured: 3 years

  3. Number of Participants Reported Regional Recurrence at 3 Years

    Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.

    Measured: 3 years

  4. Number of Participants Reported Distant Recurrence at 3 Years

    Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant> metastatic disease (other organs).

    Measured: 3 years

  5. Mortality Rates at 30- and 90-day After Sublobar Resection

    Measured: 90 days

  6. Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection

    Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.

    Measured: 90 days

  7. Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection

    The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.

    Measured: 90 days

  8. Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24

    Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.

    Measured: 24 months

  9. Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24

    Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..

    Measured: 24 months

  10. FEV1% Measured at Baseline and Month 3

    Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms

    Measured: 3 months

  11. DLCO% Measured at Baseline and Month 3

    Pulmonary function tests included percentage predicted carbon

    > monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.

    Measured: 3 months

Timeline

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

  1. First posted6 Apr 2005 (estimated)
  2. Study startJul 2005
  3. Primary completion18 Apr 2013
  4. Study completion15 Feb 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107172
Sponsor's protocol ID
ACOSOG-Z4032
Other IDs
ACOSOG-Z4032, CDR0000422346
Status last verified
Oct 2019
First submitted
5 Apr 2005
Last updated
18 Oct 2019

Publications

  • Smith RP, Schuchert M, Komanduri K, Burton S, Heron DE, Luketich JD, d'Amato T, Landreneau R. Dosimetric evaluation of radiation exposure during I-125 vicryl mesh implants: implications for ACOSOG z4032. Ann Surg Oncol. 2007 Dec;14(12):3610-3. doi: 10.1245/s10434-007-9624-0. Epub 2007 Oct 2.

    PubMed 17909906

  • Fernando HC, Landreneau RJ, Mandrekar SJ, Hillman SL, Nichols FC, Meyers B, DiPetrillo TA, Heron DE, Jones DR, Daly BD, Starnes SL, Tan A, Putnam JB. Thirty- and ninety-day outcomes after sublobar resection with and without brachytherapy for non-small cell lung cancer: results from a multicenter phase III study. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1143-51. doi: 10.1016/j.jtcvs.2011.07.051. Epub 2011 Aug 26.

    PubMed 21872277

  • Fernando HC, Landreneau RJ, Mandrekar SJ, Hillman SL, Nichols FC, Meyers B, DiPetrillo TA, Heron D, Jones DR, Daly BD, Starnes SL, Hatter JE, Putnam JB. The impact of adjuvant brachytherapy with sublobar resection on pulmonary function and dyspnea in high-risk patients with operable disease: preliminary results from the American College of Surgeons Oncology Group Z4032 trial. J Thorac Cardiovasc Surg. 2011 Sep;142(3):554-62. doi: 10.1016/j.jtcvs.2010.10.061. Epub 2011 Jul 2.

    PubMed 21724195

  • Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, Hillman SL, Heron DE, Meyers BF, DiPetrillo TA, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB Jr. Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer. J Clin Oncol. 2014 Aug 10;32(23):2456-62. doi: 10.1200/JCO.2013.53.4115. Epub 2014 Jun 30.

    PubMed 24982457

  • Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, DiPetrillo TA, Meyers BF, Heron DE, Hillman SL, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB; Alliance for Clinical Trials in Oncology. Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: results from the ACOSOG Z4032 (Alliance) multicenter randomized trial. J Thorac Cardiovasc Surg. 2015 Mar;149(3):718-25; discussion 725-6. doi: 10.1016/j.jtcvs.2014.11.003. Epub 2014 Nov 13.

    PubMed 25500100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing surgery and brachytherapy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 38 sites in 2 countries.

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 24 inclusion and 0 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: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Local Recurrence (time frame: Up to 3 years). 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 NCT00107172, which also lists 5 linked publications.

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 18 Oct 2019.

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