Conventional or Video-Assisted Surgery in Treating Patients With Lung Metastases

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003724
First received: November 1, 1999
Last updated: July 11, 2016
Last verified: July 2016

November 1, 1999
July 11, 2016
February 1999
February 2007   (final data collection date for primary outcome measure)
overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003724 on ClinicalTrials.gov Archive Site
recurrence free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Conventional or Video-Assisted Surgery in Treating Patients With Lung Metastases
Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases

RATIONALE: Video-assisted surgery may have fewer side effects than conventional surgery in patients with lung metastases. It is not yet known whether conventional surgery or video-assisted surgery is more effective in treating lung metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with that of video-assisted surgery in treating patients who have lung metastases.

OBJECTIVES: I. Compare the overall survival and failure free survival of patients with isolated pulmonary metastases treated with minimally invasive (video assisted) resection or open resection. II. Compare patterns of recurrence in these patients after these treatments, and determine what factors are predictive of recurrence. III. Describe and compare the complications and morbidity associated with minimally-invasive and open approaches to metastasectomy in these patients. IV. Test whether the patients undergoing video-assisted thoracic surgery will have a significantly better quality of life over a six month period than those undergoing an open resection.

OUTLINE: This is a randomized study. Patients are stratified according to histology (sarcoma vs epithelial vs germ cell vs melanoma) and disease laterality. After spiral CT showing pulmonary nodules are amenable to video-assisted thoracic surgery (VATS) resection with curative intent, patients are randomized to undergo either open resection (thoracotomy, median sternotomy, or bilateral sternothoracotomy) (arm I) or minimally-invasive video-assisted resection (arm II). Patients with isolated recurrence in the chest should have the recurrence(s) resected if feasible. The original resection approach (open versus VATS) should be the preferred method for the second resection, but is not required. Quality of life is assessed prior to randomization and then at 30 days, 3 months, and 6 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 530 patients accrued into this study in approximately 3 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Cancer
Procedure: surgical procedure
  • Experimental: surgery

    Patients undergo open resection (thoracotomy, median sternotomy, or bilateral sternothoracotomy).

    Patients with isolated recurrence in the chest should have the recurrence(s) resected if feasible. The original resection approach (open versus VATS) should be the preferred method for the second resection, but is not required.

    Quality of life is assessed prior to randomization and then at 30 days, 3 months, and 6 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

    Intervention: Procedure: surgical procedure
  • Experimental: video-assisted surgery

    After spiral CT showing pulmonary nodules are amenable to video-assisted thoracic surgery (VATS) resection with curative intent, patients undergo minimally-invasive video-assisted resection.

    Patients with isolated recurrence in the chest should have the recurrence(s) resected if feasible. The original resection approach (open versus VATS) should be the preferred method for the second resection, but is not required.

    Quality of life is assessed prior to randomization and then at 30 days, 3 months, and 6 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

    Intervention: Procedure: surgical procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
February 2007
February 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed pulmonary metastases (unilateral or bilateral) identified by spiral CT scan No primary lung cancer Documented previous cancer with no history of prior metastasectomy Primary tumor must be definitively controlled No evidence of primary tumor recurrence, either locally or systemically No extrapulmonary metastatic disease or evidence of mediastinal lymph node involvement Lymph nodes greater than 1.0 cm on CT scan must be proven to be benign by tissue biopsy (mediastinoscopy) All lesions must be amenable to minimally invasive resection Must be amenable to video-assisted thoracic surgery with curative intent (complete removal of all documented lesions) No greater than 4 lesions

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003724
CALGB-39804, U10CA031946, CLB-39804, CDR0000066833
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Joshua R. Sonett, MD University of Maryland Greenebaum Cancer Center
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP