Lung CancerPhase 1/2NCT00002577
Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
A Phase 1/2 study testing radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 242 sites in 2 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 242 sitesin 2 countries
- Study dates
- Jul 1995to Jan 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer of the following histologic types: Squamous cell carcinoma Adenocarcinoma Undifferentiated large cell carcinoma Not otherwise specified (i.e., diagnosis by cytology alone) Unresectable stage I, II, or III disease Measurable lesion Primary and nodal lesions encompassable within radiotherapy fields No positive supraclavicular lymph nodes (stage N3) No massive atelectasis No complete remission if treated with chemotherapy Prior cisplatin, vinblastine, etoposide, paclitaxel, carboplatin, or vinorelbine allowed All chemotherapy delivered within 4 months of entry No pleural effusion with positive cytology Other pleural effusions eligible with following requirements: Present prior to mediastinoscopy or exploratory thoracotomy Transudate cytologically negative on 2 separate thoracenteses OR Present after mediastinoscopy or exploratory thoracotomy Either transudate or exudate with negative cytology on thoracentesis OR Present only on CT and not on chest x-ray Too small to tap under CT or ultrasound guidance Ineligible for treatment on RTOG phase III studies
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic response modifier therapy Chemotherapy: See Disease Characteristics At least 6 months since prior bleomycin, mitomycin, doxorubicin, or cyclophosphamide No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic irradiation Surgery: Ineligible for definitive surgery
Trial locations and contacts
242 sites in 2 countries.
242 sites in 2 countries
United States224 sites
Akron General Medical Center
Akron, Ohio, 44302
Akron City Hospital
Akron, Ohio, 44309
Cancer Center of Albany Medical Center
Albany, New York, 12208
Saint Joseph Medical Center
Albuquerque, New Mexico, 87102
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Harrington Cancer Center
Amarillo, Texas, 79106
Providence Alaska Medical Center
Anchorage, Alaska, 99508
St. John's Medical Center
Anderson, Indiana, 46016
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Anne Arundel Oncology Center
Annapolis, Maryland, 21401
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
Harbor Hospital Center
Baltimore, Maryland, 21225
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, 21237
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, 77701
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
St. Luke's Hospital Regional Cancer Center
Bethlehem, Pennsylvania, 18015
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
New York Methodist Hospital
Brooklyn, New York, 11215-3609
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
Martha Jefferson Hospital
Charlottesville, Virginia, 22901
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Christ Hospital
Cincinnati, Ohio, 45219
Lykes Center for Radiation Therapy
Clearwater, Florida, 33757-0210
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Finger Lakes Radiation Oncology, P.C.
Clifton Springs, New York, 14432
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, 31902
CCOP - Columbus
Columbus, Ohio, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
Mount Diablo Medical Center
Concord, California, 94524-4110
Northeast Medical Center
Concord, North Carolina, 28025
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, 19023
Halifax Medical Center
Daytona Beach, Florida, 32114
CCOP - Central Illinois
Decatur, Illinois, 62526
University of Colorado Cancer Center
Denver, Colorado, 80010
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Henry Ford Hospital
Detroit, Michigan, 48202
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
John F. Kennedy Medical Center
Edison, New Jersey, 08818
Provena St. Joseph Hospital- Regional Cancer Care Center
Elgin, Illinois, 60123
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, 58122
McLaren Regional Cancer Center
Flint, Michigan, 48432
Hurley Medical Center
Flint, Michigan, 48503
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, 33901
California Cancer Center
Fresno, California, 93720
Saint Agnes Cancer Center
Fresno, California, 93720
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
University of Texas Medical Branch
Galveston, Texas, 77555-0209
Glendale Memorial Hospital and Health Center
Glendale, California, 91204
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
CCOP - Greenville
Greenville, South Carolina, 29615
RMH Regional Canter Center
Harrisonburg, Virginia, 22801
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, 17033
Catawba Memorial Hospital
Hickory, North Carolina, 28601
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Huntsville Hospital System
Huntsville, Alabama, 35801-4470
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
Clarion Health Partners Inc.
Indianapolis, Indiana, 46206-1367
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, 46219
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Dayton
Kettering, Ohio, 45429
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300
Romagosa Radiation Oncology Center
Lafayette, Louisiana, 70501
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
Loma Linda University Medical Center
Loma Linda, California, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Louisville Radiation Oncology
Louisville, Kentucky, 40215
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, 53713
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Merle M. Mahr Cancer Center
Madisonville, Kentucky, 42431
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103
CCOP - North Shore University Hospital
Manhasset, New York, 11030
Marquette General Hospital
Marquette, Michigan, 49855
Marshfield Clinic
Marshfield, Wisconsin, 54449
Loyola University Medical Center
Maywood, Illinois, 60153
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051
Veterans Affairs Medical Center - Miami
Miami, Florida, 33125
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Baptist Hospital of Miami
Miami, Florida, 33176-2197
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
MidMichigan Medical Center - Midland
Midland, Michigan, 48670
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
St. Joseph's Hospital
Milwaukee, Wisconsin, 53210
Columbia Hospital
Milwaukee, Wisconsin, 53211
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
Alabama Oncology, LLC
Montgomery, Alabama, 36106-2801
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
Ball Memorial Hospital
Muncie, Indiana, 47303-3499
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
CCOP - Ochsner
New Orleans, Louisiana, 70121
Beth Israel Medical Center
New York, New York, 10003
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
St. Anthony Hospital
Oklahoma City, Oklahoma, 73101
Nebraska Health System
Omaha, Nebraska, 68105-1018
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114
Florida Radiation Oncology Group
Orange Park, Florida, 32073
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
Bay Medical Center
Panama City, Florida, 32401
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
Bayshore Medical Center
Pasadena, Texas, 77504
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901
Cancer Care Center
Pomona, California, 91767
Atlantic City Medical Center
Pomona, New Jersey, 08240
Maine Medical Center
Portland, Maine, 04102
CCOP - Columbia River Program
Portland, Oregon, 97213
Vassar Brothers Hospital
Poughkeepsie, New York, 12601
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, 53405
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of Rochester Cancer Center
Rochester, New York, 14642
InterCommunity Cancer Center at Rome
Rome, Georgia, 30161
William Beaumont Hospital
Royal Oak, Michigan, 48073
Green Mountain Oncology Group
Rutland, Vermont, 05701
Radiation Oncology Center - Sacramento
Sacramento, California, 95816
St. Mary's Medical Center
Saginaw, Michigan, 48601
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
LDS Hospital
Salt Lake City, Utah, 84143
Radiation Medical Group, Inc.
San Diego, California, 92101-1492
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
O'Connor Hospital
San Jose, California, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, 34233
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501
Virginia Mason Medical Center
Seattle, Washington, 98111
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Deaconess Medical Center
Spokane, Washington, 99210-0248
Cancer Research for the Ozarks
Springfield, Missouri, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110
Dixie Regional Medical Center
St. George, Utah, 84770
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
Community Medical Center
Toms River, New Jersey, 08755
David Grant Medical Center
Travis Air Force Base, California, 94535
St. Francis Medical Center
Trenton, New Jersey, 08629
St. John Health System
Tulsa, Oklahoma, 74104
North Mississippi Medical Center/Cancer Center
Tupelo, Mississippi, 38801
Radiation Oncology Associates of West Alabama
Tuscallosa, Alabama, 35401
East Texas Medical Center - Cancer Institute
Tyler, Texas, 75701
New York Medical College
Valhalla, New York, 10595
Associated Radiologists, P.A.
Warren Township, New Jersey, 07059
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Schiffler Cancer Center
Wheeling, West Virginia, 26003
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
York Hospital
York, Pennsylvania, 17315
Canada18 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
McGill University
Montreal, Quebec, H2W 1S6
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY POST INDUCTION CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE, NON-SMALL CELL LUNG CANCER
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed.
Read the detailed description
OBJECTIVES: I. Assess the treatment related morbidity associated with escalating doses of 3-dimensional conformal radiotherapy (3D-CRT) in patients with locally advanced, inoperable, non-small cell lung cancer. II. Determine the maximum tolerated dose of 3D-CRT in these patients. III. Evaluate the morbidity associated with high dose 3D-CRT for carcinoma of the lung.
OUTLINE: This is a dose escalation study. Patients are stratified by the percentage of total lung volume (TLV) receiving greater than 20 Gy of radiation (less than 25% vs 25% to less than 37% vs at least 37%). As of 7/1/1999, the third stratum closed to accrual. Patients receive 3-dimensional conformal radiotherapy (3D-CRT) 5 days a week for either 6-7 weeks, 7-8 weeks, or 9-10 weeks (depending on the cohort). Within each TLV stratum, cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 15% of patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-36 patients per cohort will be accrued for this study within 1 year. As of 7/1/1999, the third stratum closed to accrual.
- Conditions
- Lung Cancer
- Being tested
- radiation therapy
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2004 (estimated)
- Study startJul 1995
- Primary completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mary V. Graham, MD, Study chair, Washington University Siteman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002577
- Sponsor's protocol ID
- RTOG-9311
- Other IDs
- CDR0000063662
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 1999
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siddiqui F, Bae K, Langer CJ, Coyne JC, Gamerman V, Komaki R, Choy H, Curran WJ, Watkins-Bruner D, Movsas B. The influence of gender, race, and marital status on survival in lung cancer patients: analysis of Radiation Therapy Oncology Group trials. J Thorac Oncol. 2010 May;5(5):631-9. doi: 10.1097/jto.0b013e3181d5e46a.
PubMed 20432520Bradley J. A review of radiation dose escalation trials for non-small cell lung cancer within the Radiation Therapy Oncology Group. Semin Oncol. 2005 Apr;32(2 Suppl 3):S111-3. doi: 10.1053/j.seminoncol.2005.03.020.
PubMed 16015546Werner-Wasik M, Swann RS, Bradley J, Graham M, Emami B, Purdy J, Sause W. Increasing tumor volume is predictive of poor overall and progression-free survival: secondary analysis of the Radiation Therapy Oncology Group 93-11 phase I-II radiation dose-escalation study in patients with inoperable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):385-90. doi: 10.1016/j.ijrobp.2007.06.034. Epub 2007 Sep 14.
PubMed 17869017Bradley J, Deasy J, Naqa IE, et al.: Predictors of lung toxicity from the RTOG 9311 radiation dose escalation trial: GTV position is important. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-67, S40, 2005.
Bradley J, Graham MV, Winter K, Purdy JA, Komaki R, Roa WH, Ryu JK, Bosch W, Emami B. Toxicity and outcome results of RTOG 9311: a phase I-II dose-escalation study using three-dimensional conformal radiotherapy in patients with inoperable non-small-cell lung carcinoma. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):318-28. doi: 10.1016/j.ijrobp.2004.06.260.
PubMed 15667949Graham MV, Winter K, Purdy JA, et al.: Preliminary results of a Radiation Therapy Oncology Group trial (RTOG 9311): a dose escalation study using 3d conformal radiation therapy in patients with inoperable nonsmall cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-34, 19-20, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY POST INDUCTION CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE, NON-SMALL CELL LUNG CANCER
- ClinicalTrials.gov ID
- NCT00002577
- Acronym / sponsor ID
- RTOG-9311
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1995
- Primary completion
- Jan 2003 (actual)
- First posted
- 27 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed.
Detailed description
OBJECTIVES: I. Assess the treatment related morbidity associated with escalating doses of 3-dimensional conformal radiotherapy (3D-CRT) in patients with locally advanced, inoperable, non-small cell lung cancer. II. Determine the maximum tolerated dose of 3D-CRT in these patients. III. Evaluate the morbidity associated with high dose 3D-CRT for carcinoma of the lung.
OUTLINE: This is a dose escalation study. Patients are stratified by the percentage of total lung volume (TLV) receiving greater than 20 Gy of radiation (less than 25% vs 25% to less than 37% vs at least 37%). As of 7/1/1999, the third stratum closed to accrual. Patients receive 3-dimensional conformal radiotherapy (3D-CRT) 5 days a week for either 6-7 weeks, 7-8 weeks, or 9-10 weeks (depending on the cohort). Within each TLV stratum, cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 15% of patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-36 patients per cohort will be accrued for this study within 1 year. As of 7/1/1999, the third stratum closed to accrual.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Background: PubMed 20432520Siddiqui F, Bae K, Langer CJ, Coyne JC, Gamerman V, Komaki R, Choy H, Curran WJ, Watkins-Bruner D, Movsas B. The influence of gender, race, and marital status on survival in lung cancer patients: analysis of Radiation Therapy Oncology Group trials. J Thorac Oncol. 2010 May;5(5):631-9. doi: 10.1097/jto.0b013e3181d5e46a.
- Background: PubMed 16015546Bradley J. A review of radiation dose escalation trials for non-small cell lung cancer within the Radiation Therapy Oncology Group. Semin Oncol. 2005 Apr;32(2 Suppl 3):S111-3. doi: 10.1053/j.seminoncol.2005.03.020.
- Results publication: PubMed 17869017Werner-Wasik M, Swann RS, Bradley J, Graham M, Emami B, Purdy J, Sause W. Increasing tumor volume is predictive of poor overall and progression-free survival: secondary analysis of the Radiation Therapy Oncology Group 93-11 phase I-II radiation dose-escalation study in patients with inoperable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):385-90. doi: 10.1016/j.ijrobp.2007.06.034. Epub 2007 Sep 14.
- Results publicationBradley J, Deasy J, Naqa IE, et al.: Predictors of lung toxicity from the RTOG 9311 radiation dose escalation trial: GTV position is important. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-67, S40, 2005.
- Results publication: PubMed 15667949Bradley J, Graham MV, Winter K, Purdy JA, Komaki R, Roa WH, Ryu JK, Bosch W, Emami B. Toxicity and outcome results of RTOG 9311: a phase I-II dose-escalation study using three-dimensional conformal radiotherapy in patients with inoperable non-small-cell lung carcinoma. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):318-28. doi: 10.1016/j.ijrobp.2004.06.260.
- Results publicationGraham MV, Winter K, Purdy JA, et al.: Preliminary results of a Radiation Therapy Oncology Group trial (RTOG 9311): a dose escalation study using 3d conformal radiation therapy in patients with inoperable nonsmall cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-34, 19-20, 2001.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary V. Graham, MD study chair
Washington University Siteman Cancer Center
242 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 242 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 242 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002577, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.