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A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone


OBJECTIVES:

Primary

- Compare overall survival of patients with previously irradiated unresectable locally
recurrent squamous cell carcinoma of the head and neck treated with radiotherapy,
cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone.

Secondary

- Compare progression-free survival of patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare quality of life, functional/performance status, and quality-adjusted survival
of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour
and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47.
Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27,
34-41, and 48-55.

- Arm II: Patients receive 1 of the following cisplatin-based* regimens at the discretion
of the treating physician:

- Regimen 1: Patients receive cisplatin* IV over 1-2 hours on day 1 and fluorouracil
IV continuously over 96 hours on days 1-4.

- Regimen 2: Patients receive cisplatin* IV over 1-2 hours and paclitaxel IV over 3
hours on day 1.

- Regimen 3: Patients receive cisplatin* IV over 1-2 hours and docetaxel IV over 1
hour on day 1.

NOTE: *Carboplatin may be substituted for cisplatin in patients with creatinine clearance <
50 mL/min or in patients who experience grade 2 or 3 neurotoxicity.

For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving complete response (CR)
receive 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this
study within 5½ years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral
cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic
variants:

- Spindle cell carcinoma

- Poorly differentiated keratin-positive carcinoma

- Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration
of the metastatic lymph node required

- Original or second primary tumor

- Recurrent neck metastases with unknown primary allowed

- Locally recurrent disease

- Measurable disease

- Unresectable disease

- Attempted surgical resection allowed provided surgery was performed ≥ 3 months
ago, wound is completely healed, and there is no sign of carotid exposure

- Must have had prior radiotherapy for SCC of the head and neck with > 75% of the
present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy

- Able to successfully re-irradiate the area of the gross tumor volume without
exceeding lifetime spinal cord dose of 54 Gy as determined by physical
examination and CT scan and/or MRI performed within the past 8 weeks

- First recurrence occurred > 6 months after completion of radiotherapy

- More than 1 recurrence allowed provided the above criteria for first
recurrence has been met

- No primary tumor of the nasopharynx or salivary gland

- No distant metastases by history or physical examination, chest CT scan, and CT scan
or MRI of the tumor site

- Patients with equivocal pulmonary nodules are eligible provided the nodules are
< 1 cm, can be safely biopsied, or are negative by positron emission tomography
imaging

- No circumferential tumor involvement of the carotid sheath by imaging unless
prophylactic carotid stent is placed

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,800/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

Hepatic

- AST or ALT < 2 times upper limit of normal (ULN)

- Bilirubin < 1.5 mg/dL

- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Renal

- Creatinine clearance > 50 mL/min

- Calcium < 11.5 mg/dL

Cardiovascular

- No New York Heart Association class III or IV heart disease

- No other symptomatic or uncontrolled cardiac disease

Pulmonary

- No chronic obstructive pulmonary disease exacerbation

- No other respiratory illness requiring hospitalization within the past 6 months or
that would preclude study therapy

Immunologic

- No AIDS

- No prior allergic reaction to E. coli-derived products

- No acute bacterial or fungal infection requiring IV antibiotics

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer,
carcinoma in situ of the breast, oral cavity, or cervix

- No pre-existing peripheral sensory neuropathy > grade 2

- No other severe active co-morbidity

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 6 months since prior chemotherapy

- No prior systemic chemotherapy for recurrent SCC of the head and neck

- Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for
initial SCC of the head and neck allowed

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- See Chemotherapy

- At least 6 months since prior radiotherapy

Surgery

- See Disease Characteristics

Other

- Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed

- At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or
other targeted agents

- No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and
neck

- No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Date of death or last follow-up

Safety Issue:

No

Principal Investigator

Stuart J. Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Federal Government

Study ID:

CDR0000429480

NCT ID:

NCT00113399

Start Date:

April 2005

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent lymphoepithelioma of the oropharynx
  • Head and Neck Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
University of California Davis Cancer CenterSacramento, California  95817
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
St. Vincent Mercy Medical CenterToledo, Ohio  43608
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
Latter Day Saints HospitalSalt Lake City, Utah  84143
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Elkhart General HospitalElkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
St. Charles Mercy HospitalOregon, Ohio  43616
Firelands Regional Medical CenterSandusky, Ohio  44870
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
West Allis Memorial HospitalWest Allis, Wisconsin  53227
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Flower Hospital Cancer CenterSylvania, Ohio  43560
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California  91767
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
St. John's Cancer Center at St. John's Medical CenterAnderson, Indiana  46016
Long Island College HospitalBrooklyn, New York  11201
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Community Memorial Hospital Cancer Care CenterMenomonee Falls, Wisconsin  53051
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Solano Radiation Oncology CenterVacaville, California  95687
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main CenterBoca Raton, Florida  33486
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Mercy General HospitalSacramento, California  95819
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois  60461
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
St. Joseph's Mercy Cancer CenterHot Springs, Arkansas  71913
MaineGeneral Medical Center - Waterville CampusWaterville, Maine  04901
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Norris Cotton Cancer Center - NorthSaint Johnsbury, Vermont  05819
Alle-Kiski Medical CenterNatrona Heights, Pennsylvania  15065