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OpenTrials
Completed

NCT Number: NCT00003724

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California San Diego Cancer Center, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Procedure

Procedure

Primary outcomes

  1. overall survival

    Time frame: Up to 5 years

Secondary outcomes

  1. recurrence free survival

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
May 21, 2004
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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