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CA-125 |
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Clinical Trial: Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
This study is not yet open for patient recruitment.
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 | Treatment or Intervention | Phase |
|---|---|---|
| stage I non-small cell lung cancer | Drug: iodine I 125 Procedure: adjuvant therapy Procedure: brachytherapy Procedure: conventional surgery Procedure: intraoperative radiotherapy Procedure: isotope therapy Procedure: radiation therapy Procedure: surgery Procedure: thoracoscopic surgery | Phase III |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Sublobar Resection With Versus Without Intraoperative Brachytherapy in High-Risk Patients With Stage I Non-Small Cell Lung Cancer
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 above, Genders Eligible for Study: Both
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, endoesophageal 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%
- DLCO ≤ 50%
- 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
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 (correlative science protocol) allowed
Location Information
Hiran C. Fernando, MD, Study Chair, University of Pittsburgh Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: March 2005
Last Updated: April 5, 2005
Record first received: April 5, 2005
ClinicalTrials.gov Identifier: NCT00107172
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- CA-125 (Lab Tests Online)

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