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

Thank you

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 Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of California Davis Cancer Center Sacramento, California  95817
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Simmons Cooper Cancer Institute Springfield, Illinois  62794-9677
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
University of Virginia Cancer Center Charlottesville, Virginia  22908
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
UPMC Cancer Centers Pittsburgh, Pennsylvania  15232
Allegheny Cancer Center at Allegheny General Hospital Pittsburgh, Pennsylvania  15212
Evanston Hospital Evanston, Illinois  60201-1781
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Methodist Hospital Houston, Texas  77030
Miriam Hospital Providence, Rhode Island  02906
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Boston University Cancer Research Center Boston, Massachusetts  02118
Valley Hospital - Ridgewood Ridgewood, New Jersey  07450
South Nassau Communities Hospital Oceanside, New York  11572
U.T. Medical Center Cancer Institute Knoxville, Tennessee  37920-6999
Jameson Memorial Hospital - North Campus New Castle, Pennsylvania  16105
Cancer Institute at St. Joseph Medical Center Towson, Maryland  21204
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center Seattle, Washington  98111