Head and Neck CancerPhase 3NCT00002727
Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
A Phase 3 study testing radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 237 sites in 2 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 237 sitesin 2 countries
- Study dates
- Apr 1996to Dec 2016
- Phase
- Phase 3
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven invasive squamous cell carcinoma of the true vocal cord
- Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas
- No verrucal carcinoma or adenocarcinoma
- No extension to pre-epiglottic space or pyriform sinus
- No fixed cord or cartilage invasion
- No evidence of adenopathy, including any of the following:
- Nodes larger than 1 cm by radiography
- Nodes containing a low central density consistent with necrosis by radiography
- Clinically palpable nodes larger than 1 cm and firm in consistency
- No recurrent or persistent disease
- No evidence or suspicion of distant metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 5 years except nonmelanomatous skin cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to the mid-neck or larynx
Surgery:
- No prior complete stripping or laser excision of all gross disease
Trial locations and contacts
237 sites in 2 countries.
237 sites in 2 countries
United States218 sites
Akron General Medical Center
Akron, Ohio, 44302
Akron City Hospital
Akron, Ohio, 44304
Cancer Center of Albany Medical Center
Albany, New York, 12208
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, 87109
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
Harrington Cancer Center
Amarillo, Texas, 79106
St. John's Medical Center
Anderson, Indiana, 46016
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0010
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
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
Harbor Hospital Center
Baltimore, Maryland, 21215-1290
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, 18015
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Bloomington Hospital
Bloomington, Indiana, 47402
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
New York Methodist Hospital
Brooklyn, New York, 11215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Green Mountain Oncology Group
Burlington, Vermont, 05401
Vermont Cancer Center
Burlington, Vermont, 05405-0075
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Christ Hospital
Cincinnati, Ohio, 45219
Barrett Cancer Center
Cincinnati, Ohio, 45267-0502
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 Center
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, 31901
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 Fitzgerald Hospital
Darby, Pennsylvania, 19023
CCOP - Dayton
Dayton, Ohio, 45429
CCOP - Central Illinois
Decatur, Illinois, 62526
University of Colorado Cancer Center
Denver, Colorado, 80010
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Henry Ford Hospital
Detroit, Michigan, 48202
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
Pocono Cancer Center
East Stroudsburg, Pennsylvania, 18301
John F. Kennedy Medical Center
Edison, New Jersey, 08818
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
Hurley Medical Center
Flint, Michigan, 48503
McLaren Regional Cancer Center
Flint, Michigan, 48532-3685
Saint Agnes Cancer Center
Fresno, California, 93720
California Cancer Center
Fresno, California, 93729-5100
University of Florida Health Science Center
Gainesville, Florida, 32610-0385
University of Texas Medical Branch
Galveston, Texas, 77555-0209
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502-1628
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
Sutter Health West 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 Cancer Center
Harrisonburg, Virginia, 22801
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
Huntsville Hospital System
Huntsville, Alabama, 35807
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
Clarian Health Partners Inc.
Indianapolis, Indiana, 46206-1367
Community Regional Cancer Care
Indianapolis, Indiana, 46219
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301-3956
Florida Radiation Oncology Group
Jacksonville, Florida, 32207
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Central Baptist Hospital
Lexington, Kentucky, 40503
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
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90025-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
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
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
Holmes Regional Medical Center
Melbourne, Florida, 32901-3276
University of Tennessee Cancer Institute
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, 33256-2110
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
Columbia Hospital
Milwaukee, Wisconsin, 53211
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Trinity Cancer Care Center
Minot, North Dakota, 58701
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
Alabama Oncology, LLC
Montgomery, Alabama, 36106-3657
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
Ball Memorial Hospital
Muncie, Indiana, 47303-3499
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-5671
Cancer Institute of New Jersey
New Brunswick, New Jersey, 38103-2807
Hospital of St. Raphael
New Haven, Connecticut, 06511
Tulane University School of Medicine
New Orleans, Louisiana, 70112-2699
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
CCOP - Ochsner
New Orleans, Louisiana, 70121
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
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
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, 68114
Nebraska Health System
Omaha, Nebraska, 68198-7460
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806-2134
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
Huntington Cancer Center
Pasadena, California, 91105
Bayshore Medical Center
Pasadena, Texas, 77504
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Abramson Cancer Center of the University of Pennsylvania
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, 19141-3098
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901
Robert and Beverly Lewis Family 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, 97225
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
All Saints Cancer Center
Racine, Wisconsin, 53405
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Bon Secours - St. Mary's Hospital
Richmond, Virginia, 23226
Massey Cancer Center
Richmond, Virginia, 23298-0058
Valley Hospital
Ridgewood, New Jersey, 07450
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
James P. Wilmot Cancer Center
Rochester, New York, 14642
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
William Beaumont Hospital
Royal Oak, Michigan, 48073
Radiation Oncology Center - Sacramento
Sacramento, California, 95816
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
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
Radiation Medical Group, Incorporated
San Diego, California, 92101
UCSF Comprehensive Cancer Center
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 - Northern Indiana CR Consortium
South Bend, Indiana, 46601
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Deaconess Medical Center
Spokane, Washington, 99204
Cancer Research for the Ozarks
Springfield, Missouri, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63108
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
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
CCOP - Toledo Community Hospital
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
William Beaumont Hospital - Troy
Troy, Michigan, 48098
St. John Health System
Tulsa, Oklahoma, 74104
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
DCH Cancer Treatment Center
Tuscaloosa, Alabama, 35401
Associated Radiologists, P.A.
Warren Township, New Jersey, 07059
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188
Schiffler Cancer Center
Wheeling, West Virginia, 26003
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Riverhill Radiation Oncology
Yonkers, New York, 10701
York Cancer Center
York, Pennsylvania, 17403
Canada19 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 4MI
McGill University
Montreal, Quebec, H2W 1S6
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
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
About this study
Official title: A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord.
PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord.
Read the detailed description
OBJECTIVES:
- Compare the local response rate in patients with stage II invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy.
- Compare the acute and late toxic effects of these regimens in this patient population.
- Compare the overall and disease-free survival patterns in this patient population treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs T2b). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks.
- Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1.6 weeks.
Patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection (at the discretion of the surgeon).
Patients are followed at 4 weeks, 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 240 patients will be accrued for this study within 3.2 years.
- Conditions
- Head and Neck Cancer
- Being tested
- radiation therapy
- Keywords
- stage II squamous cell carcinoma of the larynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy - conventional fractionation | Active comparator | Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions Receives: Radiation: radiation therapy |
| Radiation therapy - hyperfractionation | Experimental | Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control
Measured: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
Secondary outcomes (4)
Acute Toxicity
Measured: From start of treatment to 90 days
Late Toxicity
Measured: From 91 days after start of treatment to last follow-up.
Overall Survival
Measured: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years
Disease-free Survival
Measured: From randomization to date of failure (local, regional, or distant progression, second primary tumor, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 1996
- Primary completionOct 2005
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andy M. Trotti, MD, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002727
- Sponsor's protocol ID
- RTOG-9512
- Other IDs
- CDR0000064597
- Status last verified
- Dec 2016
- First submitted
- 1 Nov 1999
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
- ClinicalTrials.gov ID
- NCT00002727
- Acronym / sponsor ID
- RTOG-9512
- Conditions
- Head and Neck Cancer
- Keywords
- stage II squamous cell carcinoma of the larynx
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1996
- Primary completion
- Oct 2005 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jan 2003 (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. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord.
PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord.
Detailed description
OBJECTIVES:
- Compare the local response rate in patients with stage II invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy.
- Compare the acute and late toxic effects of these regimens in this patient population.
- Compare the overall and disease-free survival patterns in this patient population treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs T2b). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks.
- Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1.6 weeks.
Patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection (at the discretion of the surgeon).
Patients are followed at 4 weeks, 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 240 patients will be accrued for this study within 3.2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy - conventional fractionation | Active comparator | Radiation: radiation therapyRadiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions |
| Radiation therapy - hyperfractionation | Experimental | Radiation: radiation therapyRadiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions |
Who may qualify
- Ages
- 18 to 120 years
- 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 | Radiation therapy - conventional fractionation, Radiation therapy - hyperfractionation |
Primary outcome
Local Control
Time frame: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
4 secondary outcomes
Acute Toxicity
Time frame: From start of treatment to 90 days
Late Toxicity
Time frame: From 91 days after start of treatment to last follow-up.
Overall Survival
Time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years
Disease-free Survival
Time frame: From randomization to date of failure (local, regional, or distant progression, second primary tumor, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
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 4 Jan 2017.
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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.
Andy M. Trotti, MD study chair
H. Lee Moffitt Cancer Center and Research Institute
237 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 237 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 237 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Local Control (time frame: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2017.