Know Cancer

forgot password

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

Phase 3
18 Years
Not Enrolling
Metastatic Cancer

Thank you

Trial Information

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

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joshua R. Sonett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 1999

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • lung metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Lombardi Cancer Center, Georgetown University Washington, District of Columbia  20007
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
University of Missouri Columbia, Missouri  65212
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705