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

Sponsors and Collaborators:	American College of Surgeons National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00107172

Purpose

RATIONALE: 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.

PURPOSE: This randomized phase III trial is studying 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.

Condition	Intervention	Phase
Lung Cancer	Drug: iodine I 125 Procedure: brachytherapy Procedure: conventional surgery Procedure: thoracoscopic surgery	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Iodine Cadexomer iodine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to local recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:

Specific morbidity and mortality [ Designated as safety issue: No ]
Overall survival and failure-free survival [ Designated as safety issue: No ]
Freedom from regional or distant recurrence [ Designated as safety issue: No ]
Effect of histological or cytologic positive resection margins on time to local recurrence [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Pulmonary function [ Designated as safety issue: No ]

Estimated Enrollment:	226
Study Start Date:	July 2005
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.	Procedure: conventional surgery No information available Procedure: thoracoscopic surgery No information available
Arm II: Experimental Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.	Drug: iodine I 125 No information available Procedure: brachytherapy No information available Procedure: conventional surgery No information available Procedure: thoracoscopic surgery No information available

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107172

Show 64 Study Locations

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Hiran C. Fernando, MD

Boston Medical Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 Oct 2; [Epub ahead of print]

Study ID Numbers:	CDR0000422346, ACOSOG-Z4032
Study First Received:	April 5, 2005
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00107172
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Iodine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009