Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas

Sponsoren

Hauptsponsor: Radiation Therapy Oncology Group

Mitarbeiter: National Cancer Institute (NCI)
NRG Oncology

Quelle Radiation Therapy Oncology Group
Kurze Zusammenfassung

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

detaillierte Beschreibung

OBJECTIVES:

Primary

- Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin with or without surgical resection.

Secondary

- Compare local-regional control of disease and disease-free rates in patients treated with these regimens.

- Compare the acute and late toxicity of these regimens in these patients.

- Compare quality of life, perception of side effects, and performance status of patients treated with these regimens.

- Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 22, and 43.

- Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5 weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive cisplatin IV on days 1 and 22.

Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy undergo surgical resection of the primary tumor.

Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3 and 12 months, and then annually for 4 years.

Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this study within 3 years.

Gesamtstatus Unknown status
Anfangsdatum July 2002
Primäres Abschlussdatum June 2010
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Overall Survival (3-year Rate) From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.
Sekundäres Ergebnis
Messen Zeitfenster
Local-regional Control From randomization to date of failure
Disease-free Survival From randomization to date of failure
Rate of Grade 3-5 Toxicity From start of treatment to last follow-up
Quality of Life From randomization to 5 years
Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes From randomization to date of death or last follow-up
Correlation of COX-2 With Outcomes From randomization to date of death or last follow-up
Einschreibung 743
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: cisplatin

Beschreibung: 100 mg/m^2 intravenously on days 1, 22

Interventionsart: Radiation

Interventionsname: Standard fractionation RT

Beschreibung: Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy.

Armgruppenetikett: Standard fractionation RT + cisplatin

Interventionsart: Radiation

Interventionsname: Accelerated fractionation radiation therapy

Beschreibung: Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks.

Armgruppenetikett: Accelerated fractionation RT + cisplatin

Interventionsart: Procedure

Interventionsname: Conventional surgery for select patients

Beschreibung: Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer. A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made.

Teilnahmeberechtigung

Kriterien:

DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

- Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)

- No metastases below the clavicle or more distant by clinical exam or radiology

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 50 mL/min

- Calcium normal

Cardiovascular

- No symptomatic coronary artery disease (angina)

- No myocardial infarction within the past 6 months

Other

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

- No simultaneous primary tumors

- Not pregnant or nursing

- Negative pregnancy test

- 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 head and neck except radioactive iodine therapy

Surgery

- No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease

- No radical or modified neck dissection

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Phuc Felix Nguyen-Tan, MD Principal Investigator CHUM Hospital Notre Dame
Ort
Einrichtung:
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama, 35294, United States
Mobile Infirmary Medical Center | Mobile, Alabama, 36607, United States
Foundation for Cancer Research and Education | Phoenix, Arizona, 85013, United States
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona, 85259, United States
Scottsdale Healthcare - Shea | Scottsdale, Arizona, 85260, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn | Scottsdale, Arizona, 85260, United States
Providence Saint Joseph Medical Center - Burbank | Burbank, California, 91505, United States
Saint Rose Hospital | Hayward, California, 94545, United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | Inglewood, California, 90301, United States
Valley Memorial Hospital | Livermore, California, 94550, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California, 92354, United States
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California, 90033-0804, United States
Providence Holy Cross Cancer Center | Mission Hills, California, 91346-9600, United States
Highland General Hospital | Oakland, California, 94602, United States
CCOP - Bay Area Tumor Institute | Oakland, California, 94609, United States
Summit Medical Center | Oakland, California, 94609, United States
Pomona Valley Hospital Medical Center | Pomona, California, 91767, United States
Radiological Associates of Sacramento Medical Group, Inc. | Sacramento, California, 95815, United States
University of California Davis Cancer Center | Sacramento, California, 95817, United States
Naval Medical Center - San Diego | San Diego, California, 92134, United States
J.C. Robinson, M.D. Regional Cancer Center | San Pablo, California, 94806, United States
Memorial Hospital Cancer Center | Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado, 80217-3364, United States
Beebe Medical Center | Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services | Newark, Delaware, 19718, United States
St. Francis Hospital | Wilmington, Delaware, 19805, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida, 33308, United States
21st Century Oncology - Fort Myers | Fort Myers, Florida, 33901, United States
Shands Cancer Center at the University of Florida - Jacksonville | Gainesville, Florida, 32610, United States
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida, 33021, United States
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida, 32207, United States
University of Florida Shands Cancer Center | Jacksonville, Florida, 32209, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida, 33458, United States
CCOP - Mount Sinai Medical Center | Miami Beach, Florida, 33140, United States
Gulf Coast Cancer Treatment Center | Panama City, Florida, 32405, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida, 33612, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta, Georgia, 30303, United States
Emory University Hospital - Atlanta | Atlanta, Georgia, 30322, United States
John B. Amos Community Cancer Center | Columbus, Georgia, 31904, United States
Northeast Georgia Medical Center | Gainesville, Georgia, 30501, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia, 31403, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho, 83706, United States
Northwest Community Hospital | Arlington Heights, Illinois, 60005, United States
Mount Sinai Hospital Medical Center | Chicago, Illinois, 60608, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois, 60611, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois, 60657, United States
Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove, Illinois, 60515, United States
Alexian Brothers Cancer Care Center | Elk Grove Village, Illinois, 60007, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois, 60426, United States
St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana, 46016, United States
St. Francis Hospital and Health Centers | Beech Grove, Indiana, 46107, United States
Elkhart General Hospital | Elkhart, Indiana, 46515, United States
Indiana University Cancer Center | Indianapolis, Indiana, 46202, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana, 46350, United States
Saint Joseph Regional Medical Center - Plymouth Campus | Plymouth, Indiana, 46544, United States
CCOP - Northern Indiana CR Consortium | South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend | South Bend, Indiana, 46601, United States
Wendt Regional Cancer Center at Finley Hospital | Dubuque, Iowa, 52001, United States
Cancer Treatment Center at the Medical Center - Bowling Green | Bowling Green, Kentucky, 42101, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky, 40536, United States
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky, 40202, United States
Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana, 70809, United States
Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans, Louisiana, 70112, United States
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana, 70112, United States
Tulane Cancer Center | New Orleans, Louisiana, 70112, United States
New Orleans Cancer Institute at Memorial Medical Center | New Orleans, Louisiana, 70115, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland, 21401, United States
Union Hospital Cancer Center at Union Hospital | Elkton, Maryland, 21921, United States
Massachusetts General Hospital Cancer Center | Boston, Massachusetts, 02114, United States
Cancer Research Center at Boston Medical Center | Boston, Massachusetts, 02118, United States
Hudner Oncology Center at Saint Anne's Hospital | Fall River, Massachusetts, 02721, United States
Cape Cod Hospital | Hyannis, Massachusetts, 02601, United States
South Suburban Oncology Center | Quincy, Massachusetts, 02169, United States
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan, 48100, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan, 48106-0995, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan, 48123, United States
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, 48201-1379, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center | Detroit, Michigan, 48236, United States
Hurley Medical Center | Flint, Michigan, 48502, United States
Genesys Hurley Cancer Institute | Flint, Michigan, 48532, United States
Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint, Michigan, 48532, United States
Borgess Medical Center | Kalamazoo, Michigan, 49001, United States
CCOP - Kalamazoo | Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital | Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center | Kalamazoo, Michigan, 49007, United States
Seton Cancer Institute - Saginaw | Saginaw, Michigan, 48601, United States
St. John Macomb Hospital | Warren, Michigan, 48903, United States
Mayo Clinic Cancer Center | Rochester, Minnesota, 55905, United States
Cancer Institute of Cape Girardeau | Cape Girardeau, Missouri, 63703, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri, 65203, United States
CCOP - Kansas City | Kansas City, Missouri, 64131, United States
Saint Louis University Cancer Center | Saint Louis, Missouri, 63110, United States
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri, 63110, United States
CCOP - Cancer Research for the Ozarks | Springfield, Missouri, 65802, United States
St. John's Regional Health Center | Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri, 65807, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska, 68114, United States
University Medical Center of Southern Nevada | Las Vegas, Nevada, 89102, United States
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada, 89106, United States
Washoe Cancer Services at Washoe Medical Center - Reno | Reno, Nevada, 89502, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey, 08103, United States
Monmouth Medical Center | Long Branch, New Jersey, 07740, United States
South Jersey Healthcare Regional Cancer Center | Millville, New Jersey, 08332, United States
Fox Chase Virtua Health Cancer Program - Marlton | Mount Holly, New Jersey, 08060, United States
Community Medical Center | Toms River, New Jersey, 08755, United States
New York Methodist Hospital | Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States
CCOP - North Shore University Hospital | Manhasset, New York, 11030, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York, 12901, United States
SUNY Upstate Medical University Hospital | Syracuse, New York, 13210, United States
Randolph Hospital | Asheboro, North Carolina, 27203, United States
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden, North Carolina, 27288, United States
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology | Goldsboro, North Carolina, 27534, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina, 27401, United States
Annie Penn Cancer Center | Reidsville, North Carolina, 27320, United States
Rutherford Hospital | Rutherfordton, North Carolina, 28139, United States
Wilson Medical Center | Wilson, North Carolina, 27893, United States
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina, 27157, United States
Trinity Cancer Care Center | Minot, North Dakota, 58701, United States
Akron City Hospital at Summa Health System | Akron, Ohio, 44304, United States
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio, 44307, United States
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio, 44710-1799, United States
Grandview Hospital | Dayton, Ohio, 45405, United States
Good Samaritan Hospital | Dayton, Ohio, 45406, United States
Miami Valley Hospital | Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center | Dayton, Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton | Dayton, Ohio, 45428, United States
CCOP - Dayton | Dayton, Ohio, 45429, United States
Charles F. Kettering Memorial Hospital | Kettering, Ohio, 45429, United States
St. Rita's Medical Center | Lima, Ohio, 45801, United States
Middletown Regional Hospital | Middletown, Ohio, 45044, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio, 44460, United States
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio, 45373, United States
Cancer Treatment Center | Wooster, Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio, 45385, United States
LaFortune Cancer Center at St. John Health System | Tulsa, Oklahoma, 74104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma, 74136, United States
Abington Memorial Hospital | Abington, Pennsylvania, 19001, United States
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania, 19010, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033-0850, United States
Cancer Center at Paoli Memorial Hospital | Paoli, Pennsylvania, 19301, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111-2497, United States
Albert Einstein Cancer Center | Philadelphia, Pennsylvania, 19141, United States
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania, 15219, United States
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania, 18501, United States
CCOP - MainLine Health | Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania, 19096, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina, 29621, United States
Bon Secours St. Francis Health System | Greenville, South Carolina, 29601, United States
Greenville Hospital System Cancer Center | Greenville, South Carolina, 29605, United States
CCOP - Greenville | Greenville, South Carolina, 29615, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina, 29303, United States
CCOP - Upstate Carolina | Spartanburg, South Carolina, 29304, United States
Rapid City Regional Hospital | Rapid City, South Dakota, 57701, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee, 37232, United States
Harrington Cancer Center | Amarillo, Texas, 79106, United States
Brooke Army Medical Center | Fort Sam Houston, Texas, 78234, United States
M.D. Anderson Cancer Center at University of Texas | Houston, Texas, 77030, United States
Wilford Hall Medical Center | Lackland Air Force Base, Texas, 78236, United States
Cottonwood Hospital Medical Center | Murray, Utah, 84107, United States
McKay-Dee Hospital Center | Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo | Provo, Utah, 84603, United States
Dixie Regional Medical Center | Saint George, Utah, 84770, United States
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah, 84112, United States
LDS Hospital | Salt Lake City, Utah, 84143, United States
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont, 05401, United States
Danville Regional Medical Center | Danville, Virginia, 24541, United States
Rappahannock General Hospital | Kilmarnock, Virginia, 22482, United States
Naval Medical Center - Portsmouth | Portsmouth, Virginia, 23708-2197, United States
Veterans Affairs Medical Center - Richmond | Richmond, Virginia, 23249, United States
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia, 23298-0037, United States
Community Memorial Health Center | South Hill, Virginia, 23970-0090, United States
North Star Lodge Cancer Center | Yakima, Washington, 98902, United States
Washington Hematology - Oncology Specialists | Yakima, Washington, 98902, United States
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia, 26003, United States
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin, 54301-3526, United States
St. Vincent Hospital | Green Bay, Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center | Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin, 54601, United States
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin, 53792, United States
Holy Family Memorial Medical Center | Manitowoc, Wisconsin, 54221, United States
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin, 54143, United States
Community Memorial Hospital | Menomonee Falls, Wisconsin, 53051, United States
St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus | Milwaukee, Wisconsin, 53211, United States
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin, 53295, United States
Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin, 53066-3896, United States
All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin, 53188, United States
Standort Länder

United States

Überprüfungsdatum

May 2017

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Standard fractionation RT + cisplatin

Art: Other

Beschreibung: Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.

Etikette: Accelerated fractionation RT + cisplatin

Art: Experimental

Beschreibung: Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov