Clinical trial NCT00004917: Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer
Official title: A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Head and Neck Cancer
Keywords: stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
anemia
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer.

Detailed description: OBJECTIVES:

Primary

* Determine whether epoetin alfa given during definitive radiotherapy or chemoradiotherapy improves the local-regional control rate in anemic patients with squamous cell carcinoma of the head and neck.

Secondary

* Determine whether this drug improves survival in this patient population.
* Identify patterns in first failure in these patients.
* Determine whether there is a significant increase in hemoglobin level between the baseline value and the value at 28 days after starting epoetin alfa in these patients.
* Assess the toxicity of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to stage (I/II vs III/IV without chemotherapy vs III/IV with chemotherapy), pretreatment hemoglobin level (9.0 to less than 11.5 g/dL vs 11.5 to 13.5 g/dL), and gender. Patients are randomized to one of two treatment arms.

* Arm I: Patients with stage I or II disease undergo radiotherapy once daily for 6-7 weeks. Patients with stage III or IV disease undergo radiotherapy once daily for 3.5 weeks and then twice daily (6 hours apart) for 2.5 weeks for a total of 6 weeks.
* Arm II: Patients undergo radiotherapy as in arm I. Beginning 7-10 days before radiotherapy, patients receive epoetin alfa subcutaneously once weekly until the end of radiotherapy.

Patients with stage III/IV disease may receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 of radiotherapy.

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

PROJECTED ACCRUAL: A total of 372 patients (186 per arm) will be accrued for this study within 3.5 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed invasive squamous cell carcinoma of the head and neck, including carcinoma arising from the oral cavity, oropharynx, larynx, and hypopharynx

  * Stage I-IV disease
  * No distant metastases
  * No carcinoma of the nasopharynx, nasal cavity/paranasal sinuses, or salivary glands
  * No carcinoma in situ without an identifiable invasive component
* Plan for radiotherapy in continuous course
* Prior surgical exploration with gross residual disease remaining allowed
* Prior neck dissection with or without biopsy of primary tumor, but no radical surgery for primary tumor, allowed
* Anemia, defined as hemoglobin no greater than 13.5 g/dL for males and no greater than 12.5 g/dL for females (transfusion prior to study allowed)

  * No severe anemia (i.e., hemoglobin less than 9.0 g/dL)
  * No anemia confirmed to be due to causes other than chronic disease (e.g., iron deficiency anemia)
* Not entered on other RTOG head and neck protocols

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics
* Stage III/IV patients receiving concurrent cisplatin:

  * Absolute neutrophil count at least 2,000/mm\^3
  * Platelet count at least 100,000/mm\^3

Hepatic:

* Not specified

Renal:

* Stage III/IV patients receiving concurrent cisplatin:

  * Creatinine no greater than 1.5 mg/dL
  * Creatinine clearance at least 50 mL/min

Cardiovascular:

* No malignant or poorly controlled hypertension (e.g., symptomatic hypertension or diastolic blood pressure of 100 mm Hg or greater despite antihypertensive medication)
* No unstable angina or other poorly controlled cardiac disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* If stage III or IV disease is present, willing to come for twice daily radiotherapy for the last 2.5 weeks of therapy
* No active infection requiring IV antibiotics
* No unexplained fever
* No AIDS or other history of congenital or acquired immunodeficiency
* No other malignancies within the past 3 years except carcinoma in situ or nonmelanomatous skin cancer
* No known hypersensitivity to mammalian cell-derived products or to human albumin
* No acute/subacute illness that would make the need for transfusion likely

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since other prior cytokine therapy (e.g., filgrastim \[G-CSF\], interleukins, or interferons)
* No prior epoetin alfa
* No other concurrent cytokine therapy

Chemotherapy:

* No prior chemotherapy
* Concurrent cisplatin, paclitaxel/cisplatin, or paclitaxel/carboplatin for patients with stage III/IV disease is allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy to the head and neck

Surgery:

* See Disease Characteristics

Other:

* No concurrent amifostine
* No concurrent transfusion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
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facility: Maine Medical Center
state: Maine
city: Annapolis
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city: Boston
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city: Boston
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facility: Boston Medical Center
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city: Hyannis
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facility: Cape Cod Hospital
state: Massachusetts
city: Jamaica Plain
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facility: Veterans Affairs Medical Center - Boston (Jamaica Plain)
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city: Peabody
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city: Ann Arbor
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state: Michigan
city: Ann Arbor
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facility: University of Michigan Comprehensive Cancer Center
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city: Springfield
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city: Billings
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city: Omaha
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facility: Comprehensive Cancer Centers of Nevada
state: Nevada
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state: New Hampshire
city: Manchester
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city: Edison
country: United States
facility: John F. Kennedy Medical Center
state: New Jersey
city: Elizabeth
country: United States
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state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Millville
country: United States
facility: South Jersey Regional Cancer Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
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city: Pomona
country: United States
facility: Atlantic City Medical Center
state: New Jersey
city: Princeton
country: United States
facility: Medical Center of Princeton
state: New Jersey
city: Ridgewood
country: United States
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city: Toms River
country: United States
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city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Warren
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facility: Associated Radiologists, P.A.
state: New Jersey
city: Albuquerque
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facility: Radiation Oncology Associates of Albuquerque
state: New Mexico
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country: United States
facility: Cancer Center of Albany Medical Center
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city: Brooklyn
country: United States
facility: State University of New York Health Science Center at Brooklyn
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Clifton Springs
country: United States
facility: Finger Lakes Radiation Oncology Center
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center
state: New York
city: Plattsburgh
country: United States
facility: Champlain Valley Physicians Hospital Medical Center
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center
state: New York
city: Syracuse
country: United States
facility: CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
state: New York
city: Yonkers
country: United States
facility: Riverhill Radiation Oncology
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Concord
country: United States
facility: Northeast Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University School of Medicine
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city: Winston-Salem
country: United States
facility: CCOP - Southeast Cancer Control Consortium
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city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Minot
country: United States
facility: Trinity Cancer Care Center
state: North Dakota
city: Akron
country: United States
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state: Ohio
city: Akron
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city: Cincinnati
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facility: Barrett Cancer Center
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city: Cincinnati
country: United States
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city: Cleveland
country: United States
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city: Cleveland
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facility: University Hospitals of Cleveland
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city: Cleveland
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city: Columbus
country: United States
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state: Ohio
city: Columbus
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city: Parma
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city: Oklahoma City
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city: Tulsa
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city: Abington
country: United States
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city: Hershey
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city: Philadelphia
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facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Veterans Affairs Medical Center - Philadelphia
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city: Philadelphia
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
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state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Reading
country: United States
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state: Pennsylvania
city: Scranton
country: United States
facility: Mercy Hospital Cancer Center - Scranton
state: Pennsylvania
city: Wilkes-Barre
country: United States
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state: Pennsylvania
city: Wynnewood
country: United States
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state: Pennsylvania
city: York
country: United States
facility: York Cancer Center
state: Pennsylvania
city: Providence
country: United States
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state: Rhode Island
city: Greenville
country: United States
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state: South Carolina
city: Spartanburg
country: United States
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state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Amarillo
country: United States
facility: Harrington Cancer Center
state: Texas
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Pasadena
country: United States
facility: Bayshore Medical Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Provo
country: United States
facility: Utah Valley Regional Medical Center - Provo
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Salt Lake City
country: United States
facility: Latter Day Saints Hospital
state: Utah
city: Bennington
country: United States
facility: Green Mountain Oncology Group
state: Vermont
city: Burlington
country: United States
facility: Vermont Cancer Center
state: Vermont
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Harrisonburg
country: United States
facility: RMH Regional Cancer Center
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center, Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Bon Secours - St. Mary's Hospital
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
city: Wheeling
country: United States
facility: Schiffler Cancer Center
state: West Virginia
city: Green Bay
country: United States
facility: CCOP - St. Vincent Hospital Cancer Center, Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundation
state: Wisconsin
city: Madison
country: United States
facility: Southern Wisconsin Radiotherapy Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Community Memorial Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
city: Racine
country: United States
facility: All Saints Cancer Center
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital Regional Cancer Center
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Moncton
country: Canada
facility: Doctor Leon Richard Oncology Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. Johns
country: Canada
facility: Newfoundland Cancer Treatment and Research Foundation
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Cancer Care Ontario-Hamilton Regional Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre, Sudbury
state: Ontario
city: Thunder Bay
country: Canada
facility: Northwestern Ontario Regional Cancer Centre, Thunder Bay
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Gyeonggi
country: Korea, Republic of
facility: Jin Soo Lee Practice Inc.
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Mitchell Machtay, MD
role: STUDY_CHAIR
References:
citation: Machtay M, Pajak TF, Suntharalingam M, Shenouda G, Hershock D, Stripp DC, Cmelak AJ, Schulsinger A, Fu KK; Radiation Therapy Oncology Group. Radiotherapy with or without erythropoietin for anemic patients with head and neck cancer: a randomized trial of the Radiation Therapy Oncology Group (RTOG 99-03). Int J Radiat Oncol Biol Phys. 2007 Nov 15;69(4):1008-17. doi: 10.1016/j.ijrobp.2007.04.063. Epub 2007 Aug 23.
citation: Machtay M, Pajak T, Suntharalingam M, et al.: Definitive radiotherapy +/- erythropoietin for squamous cell carcinoma of the head and neck: preliminary report of RTOG 99-03. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-5, S132, 2004.