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


Phase 3
18 Years
N/A
Not Enrolling
Both
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
years.

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
Characteristics

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000066833

NCT ID:

NCT00003724

Start Date:

February 1999

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
University of MissouriColumbia, Missouri  65212
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705