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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


OBJECTIVES:

Primary

- Compare time to local recurrence, in terms of recurrence within the same lobe or hilum
(N1 nodes) or progression at the staple line (after treatment effects [i.e., scarring]
have subsided), in high-risk patients with stage I non-small cell lung cancer treated
with sublobar resection with vs without intraoperative brachytherapy.

Secondary

- Compare procedure-specific morbidity and mortality in patients treated with these
regimens.

- Compare overall and failure-free survival of patients treated with these regimens.

- Compare freedom from regional or distant recurrence in patients treated with these
regimens.

- Determine the effect of histologically or cytologically positive resection margins on
time to local recurrence in patients treated with these regimens.

- Determine the effect of brachytherapy on quality of life of these patients.

- Determine the effect of brachytherapy on pulmonary function in these patients.

OUTLINE: This is a randomized, multicenter study. 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 an iodine I 125 implant at the resection margin.

Quality of life is assessed at baseline and then at 3, 12, and 24 months.

After completion of study treatment, patients are followed at 3 and 6 months, every 6 months
for 2.5 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Suspected or proven non-small cell lung cancer (NSCLC), meeting both of the following
criteria:

- Pre-operative criteria

- Lung nodule suspicious for clinical stage I NSCLC

- Mass ≤ 3 cm in maximum diameter by CT scan of the chest and upper
abdomen

- Clinical stage IA OR selected stage IB with visceral pleural
involvement

- Intra-operative criteria

- Histologically proven stage I NSCLC

- All suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on
CT scan OR positive on positron-emission tomography scan) must be
negative by mediastinoscopy, endoscopic ultrasound-guided needle
aspiration, or CT-guided, video-assisted thoracoscopic, or open lymph
node biopsy

- Meets ≥ 1 major OR ≥ 2 minor high-risk criteria, defined as the following:

- Major criteria

- FEV_1 ≤ 50% of predicted

- DLCO ≤ 50% of predicted

- Minor criteria

- Age 75 and over

- FEV_1 51-60% of predicted

- DLCO 51-60% of predicted

- Pulmonary hypertension, defined as pulmonary artery systolic pressure > 40
mm Hg by echocardiography or right heart catheterization

- LVEF ≤ 40%

- Resting or exercise arterial oxygen partial pressure ≤ 55 mm Hg or oxygen
saturation ≤ 88% by pulse oximetry

- Arterial carbon dioxide partial pressure > 45 mm Hg

- Modified Medical Research Council Dyspnea Scale ≥ 3

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- See Disease Characteristics

Pulmonary

- See Disease Characteristics

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- More than 5 years since prior invasive malignancy unless non melanoma skin cancer or
in-situ cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No prior intrathoracic radiotherapy

Surgery

- Not specified

Other

- Concurrent enrollment on ACOSOG-Z4031 (correlative science protocol) allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Time to local recurrence

Safety Issue:

No

Principal Investigator

Hiran C. Fernando, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000422346

NCT ID:

NCT00107172

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of California Davis Cancer CenterSacramento, California  95817
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
Evanston HospitalEvanston, Illinois  60201-1781
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Methodist HospitalHouston, Texas  77030
Miriam HospitalProvidence, Rhode Island  02906
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Boston University Cancer Research CenterBoston, Massachusetts  02118
Valley Hospital - RidgewoodRidgewood, New Jersey  07450
South Nassau Communities HospitalOceanside, New York  11572
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
Jameson Memorial Hospital - North CampusNew Castle, Pennsylvania  16105
Cancer Institute at St. Joseph Medical CenterTowson, Maryland  21204
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical CenterSeattle, Washington  98111