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Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
This study is ongoing, but not recruiting participants.
First Received: June 5, 2003   Last Updated: April 14, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062439
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: docetaxel
Drug: etoposide
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Measurability of lesions [ Designated as safety issue: No ]
  • Objective status [ Designated as safety issue: No ]
  • Response [ Designated as safety issue: No ]
  • Performance status [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to death [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2003
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the feasbility of administering induction chemoradiotherapy comprising cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in patients with non-small cell lung cancer involving the superior sulcus (Pancoast tumors).
  • Determine overall survival of patients treated with this regimen.
  • Determine time to progression in patients treated with this regimen.
  • Determine confirmed and unconfirmed and complete and partial response during induction in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE:

  • Induction chemoradiotherapy: Patients receive etoposide IV over 1 hour on days 1-5 and 29-33 and cisplatin IV over 1 hour on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy once daily 5 days a week for 5 weeks.

Within 2-4 weeks after completion of induction chemoradiotherapy, patients undergo disease evaluation. Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks. Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete.

  • Consolidation chemotherapy: Within 3-8 weeks after thoracotomy, patients with no evidence of disease progression receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Any of the following stages due to involvement of the superior sulcus:

      • Stage IIB (T3, N0), IIIA (T3, N1), or IIIB (T4, N0-1)
    • Newly diagnosed
    • Primary bronchogenic
  • Must meet 1 of the following tumor involvement criteria:

    • An apical tumor associated with the Pancoast syndrome (arm or shoulder pain and/or neurologic findings corresponding to the roots of C-8 and/or T-1 or the inferior trunk of the bronchial plexus with or without Horner's syndrome) without rib or vertebral body involvement
    • Superior sulcus tumors with involvement of the chest wall (T3), usually ribs 1 and 2 by CT scan or MRI, with or without an associated Pancoast syndrome
    • Superior sulcus tumors with invasion of the vertebral bodies or involvement of the subclavian vessels (T4) by CT scan or MRI, with or without an associated Pancoast syndrome
  • No more than 1 parenchymal lesion in the same lung or in both lungs
  • No involvement of the following lymph node groups as determined by mediastinal exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy) within the past 42 days:

    • Single-level or multi-level ipsilateral or contralateral mediastinal nodal (N2 or N3) disease by mediastinoscopy, thoracoscopy, mediastinotomy, thoracotomy, or transbronchial Wang needle biopsy, regardless of whether enlarged nodes are visible or not on chest x-ray or CT scan
    • Supraclavicular (scalene) nodes

      • Any nodes evident on physical exam must be biopsied by fine needle aspiration or open biopsy
    • Left upper lobe tumors with left vocal cord paralysis by indirect laryngoscopy (presumes N2 nodes in the A-P window) NOTE: *Mediastinal exploration is not required for patients whose mediastinum is negative by both positron-emission tomography (PET) and CT scan
  • No pleural effusions except if 1 of the following criteria are met:

    • Pleural effusion present before mediastinoscopy or thoracotomy with negative cytology on 2 separate thoracenteses
    • Pleural effusion present only after exploratory or staging thoracotomy, with negative cytology on a single thoracentesis
    • Present only on CT scan and too small to tap
  • No pericardial effusions or superior vena cava syndrome
  • No brain metastases by CT scan or MRI
  • No evidence of distant metastatic disease by bone scan or PET
  • Must be a candidate for potential future pulmonary resection

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Zubrod 0-2

    • Patients with Zubrod performance status 2 must have an albumin level at least 0.85 times lower limit of normal and weight loss no greater than 10%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
  • SGOT or SGPT no greater than 1.5 times ULN* NOTE: *Unless due to a documented benign disease

Renal

  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No active angina
  • No unstable heart rhythms
  • No clinically evident congestive heart failure

Pulmonary

  • Preresection FEV_1 at least 2.0 L OR
  • Predicted postresection FEV_1 greater than 1.0 L

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled peptic ulcer disease
  • No grade 2 or greater sensory neuropathy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent colony-stimulating factors during chemoradiotherapy or course 1 of consolidation therapy

Chemotherapy

  • No prior chemotherapy for lung cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the neck or thorax
  • No concurrent intensity-modulated radiotherapy

Surgery

  • Prior exploratory thoracotomy allowed only for diagnosis or staging purposes

Other

  • No concurrent amifostine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062439

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Colorado
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
Wesley Medical Center
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Hackley Hospital
Muskegon, Michigan, United States, 49442
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Holland Community Hospital
Holland, Michigan, United States, 49423
Hurley Medical Center
Flint, Michigan, United States, 48503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Metro Health Hospital
Grand Rapids, Michigan, United States, 49506
Munson Medical Center
Traverse City, Michigan, United States, 49684
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. John Macomb Hospital
Warren, Michigan, United States, 48093
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
Missouri Baptist Cancer Center
St. Louis, Missouri, United States, 63131
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Great Falls, Montana, United States, 59405
Community Medical Center
Missoula, Montana, United States, 59801
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
United States, North Carolina
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Oregon
Northwest Cancer Specialists at Rose Quarter Cancer Center
Portland, Oregon, United States, 97227
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208-3599
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
LDS Hospital
Salt Lake City, Utah, United States, 84103
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Logan Regional Hospital
Logan, Utah, United States, 84321
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Allenmore Hospital
Tacoma, Washington, United States, 98405
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
CCOP - Northwest
Tacoma, Washington, United States, 98405
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Group Health Central Hospital
Seattle, Washington, United States, 98112
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Polyclinic First Hill
Seattle, Washington, United States, 98122
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States, 98684
St. Clare Hospital
Tacoma, Washington, United States, 98499
St. Francis Hospital
Federal Way, Washington, United States, 98003
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, West Virginia
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Investigators
Study Chair: Michael J. Kraut, MD Providence Cancer Institute at Providence Hospital - Southfield Campus
Study Chair: Tien Hoang, MD University of Wisconsin, Madison
Study Chair: Valerie W. Rusch, MD, FACS Memorial Sloan-Kettering Cancer Center
Study Chair: James R. Jett, MD Mayo Clinic
Study Chair: Scott A. Laurie, MD, FRCPC Ottawa Hospital Regional Cancer Centre - General Campus
Study Chair: Alan P. Lyss, MD Missouri Baptist Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers: CDR0000304777, SWOG-S0220, ECOG-S0220, ACOSOG-SWOG-S0220, NCCTG-SWOG-S0220, CAN-NCIC-SWOG-S0220, CALGB-30501
Study First Received: June 5, 2003
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00062439     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Pancoast's Syndrome
Etoposide phosphate
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Antineoplastic Agents, Phytogenic
Etoposide
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009