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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
Open (Enrolling)
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



- 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.


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

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

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

- 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


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

- 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

- Clinical stage IA OR selected stage IB with visceral pleural

- 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



- 18 and over

Performance status

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- See Disease Characteristics


- See Disease Characteristics


- 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


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- No prior intrathoracic radiotherapy


- Not specified


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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Time to local recurrence

Safety Issue:


Principal Investigator

Hiran C. Fernando, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center


United States: Federal Government

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

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



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