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A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients With Advanced Oropharyngeal Squamous Cell Cancer


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

Thank you

Trial Information

A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients With Advanced Oropharyngeal Squamous Cell Cancer


OBJECTIVES:

Primary

- Compare the overall survival of patients with previously untreated stage III or IV
squamous cell carcinoma of the oropharynx treated with induction chemotherapy
comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and
cisplatin versus radiotherapy and cisplatin only.

- Compare the progression-free survival in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life and functional status of patients treated with these
regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
primary cancer site (base of tongue vs other), nodal extent (N0-1 vs N2-3), radiotherapy
plan (conventional [2-D or 3-D conformal radiotherapy] vs intensity modulated radiotherapy).
Patients are randomized to 1 of 2 treatment arms.

- Arm I (induction chemotherapy with or without salvage surgery followed by
chemoradiotherapy)

- Induction chemotherapy with or without early salvage surgery: Patients receive
docetaxel IV over 1 hour and cisplatin over 30-60 minutes on day 1 and
fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 1-3
courses. Patients achieving complete or partial response at the primary site after
course 1 receive 2 additional courses of therapy and then proceed to
chemoradiotherapy within 3-4 weeks after completion of fluorouracil
administration. Patients with stable disease or surgically resectable locoregional
disease progression undergo early salvage surgery and then proceed to concurrent
chemoradiotherapy within 70 days after surgery. Patients with locoregional
unresectable disease progression or patients who refused early salvage surgery
proceed directly to concurrent chemoradiotherapy within 3-4 weeks after completion
of fluorouracil administration.

- Chemoradiotherapy: Patients undergo 2-D or 3-D conformal radiotherapy or intensity
modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin
IV over 30-60 minutes concurrently on days 1, 22, and 43* in the absence of
disease progression or unacceptable toxicity.

NOTE: *Patients undergoing surgery before chemoradiotherapy receive cisplatin on days 1 and
22 only of a 6-week course of radiotherapy.

- Arm II (chemoradiotherapy only): Patients undergo 2-D or 3-D conformal radiotherapy or
intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive
cisplatin IV over 30-60 minutes on days 1, 22, and 43 in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline, after completion of chemoradiotherapy, and then at
12 months after randomization.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: Approximately 398 patients (199 per treatment arm) will be accrued for
this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the oropharynx by biopsy or fine
needle aspiration of the primary lesion or neck mass

- Selected stage III or IV disease

- No T1-2, N1 disease

- No T4b disease

- No other primary tumor sites or unknown primary tumor sites

- Previously untreated disease

- Measurable or non-measurable disease by clinical exam, CT scan or MRI

- Disease considered to be curatively resectable

- Patients for whom surgical excision is unlikely to result in clear margins are
not eligible, including patients with any of the following:

- Gross extension of tumor to skull base (e.g., T4b disease)

- Severe trismus

- Pterygoid plate erosion

- Sphenoid bone or foramen ovale involvement

- Direct extension to involve prevertebral-fascia

- Extension to superior nasopharynx or eustachian tube

- Direct extension into the neck with involvement of the deep neck
musculature (neck node fixation)

- Suspected invasion (encasement) of the common or internal carotid arteries
(T4b)

- Direct extension of neck disease to involve the external skin

- Regional metastases to the supraclavicular neck (IVB low level VB nodes)

- Disease must be appropriate for definitive radiotherapy with curative intent

- No evidence of distant metastases (M1)

- Must have negative chest x-ray

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- No myocardial infarction within the past 3 months

- No unstable or uncontrolled angina

- No active systemic infection

- Granulocyte count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Creatinine < 1.5 mg/dL

- Bilirubin normal

- Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 1.5 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of hypersensitivity reaction to products containing polysorbate 80

- No medical contraindication to surgery as defined by the treating institution

- No clinically significant motor or sensory neuropathy ≥ grade 2

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer
from which the patient is in complete remission

PRIOR CONCURRENT THERAPY:

- No prior therapeutic surgery for head and neck cancer

- No prior radiotherapy

- No prior chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 2 years

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David J. Adelstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000459847

NCT ID:

NCT00268372

Start Date:

December 2005

Completion Date:

December 2007

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
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
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
St. Rita's Medical CenterLima, Ohio  45801
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Hinsdale, Illinois  60521
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Wesley Medical CenterWichita, Kansas  67214
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Latter Day Saints HospitalSalt Lake City, Utah  84143
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Southwest Medical CenterLiberal, Kansas  67901
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Trinity Medical Center - EastMoline, Illinois  61265
Bettendorf, Iowa  52722
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Capital Health System Regional Cancer CenterTrenton, New Jersey  08618
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303