S0427, Combination Chemotherapy & RT in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx

Last updated: October 3, 2012
Sponsor: Southwest Oncology Group
Overall Status: Terminated

Phase

3

Condition

Head And Neck Cancer

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

N/A

Clinical Study ID

NCT00268372
CDR0000459847
U10CA032102
S0427
  • Ages > 18
  • All Genders

Study Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known whether giving combination chemotherapy together with radiation therapy is more effective than giving cisplatin together with radiation therapy in treating cancer of the oropharynx.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 6
Study Start date:
December 01, 2005
Estimated Completion Date:
December 31, 2007

Study Description

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.

Connect with a study center

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Rush-Copley Cancer Care Center

    Aurora, Illinois 60507
    United States

    Site Not Available

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois 60612-3785
    United States

    Site Not Available

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois 60141
    United States

    Site Not Available

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Trinity Medical Center - East

    Moline, Illinois 61265
    United States

    Site Not Available

  • Moline, Illinois 61265
    United States

    Site Not Available

  • West Suburban Center for Cancer Care

    River Forest, Illinois 60305
    United States

    Site Not Available

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois 62781-0001
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Bettendorf, Iowa 52722
    United States

    Site Not Available

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Siouxland Regional Cancer Center

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas 66720
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas 67801
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas 67068
    United States

    Site Not Available

  • Southwest Medical Center

    Liberal, Kansas 67901
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas 67114
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas 67357
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas 67124
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas 67042
    United States

    Site Not Available

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas 67401
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas 67152
    United States

    Site Not Available

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas 67203
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas 67208
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Wesley Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas 67156
    United States

    Site Not Available

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109-0942
    United States

    Site Not Available

  • Bronson Methodist Hospital

    Kalamazoo, Michigan 49007
    United States

    Site Not Available

  • West Michigan Cancer Center

    Kalamazoo, Michigan 49007-3731
    United States

    Site Not Available

  • Borgess Medical Center

    Kalamazooaa, Michigan 49001
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Saint Louis University Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri 65802
    United States

    Site Not Available

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri 65807
    United States

    Site Not Available

  • St. John's Regional Health Center

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Capital Health System Regional Cancer Center

    Trenton, New Jersey 08618
    United States

    Site Not Available

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina 27534
    United States

    Site Not Available

  • Wayne Radiation Oncology

    Goldsboro, North Carolina 27534
    United States

    Site Not Available

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina 28501
    United States

    Site Not Available

  • Rutherford Hospital

    Rutherfordton, North Carolina 28139
    United States

    Site Not Available

  • Wilson Medical Center

    Wilson, North Carolina 27893-3428
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio 44131
    United States

    Site Not Available

  • St. Rita's Medical Center

    Lima, Ohio 45801
    United States

    Site Not Available

  • Cleveland Clinic - Wooster

    Wooster, Ohio 44691
    United States

    Site Not Available

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania 18105
    United States

    Site Not Available

  • AnMed Health Cancer Center

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

  • Wilford Hall Medical Center

    Lackland AFB, Texas 78236
    United States

    Site Not Available

  • Cancer Therapy and Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University Hospital - San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229-3900
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas 78209
    United States

    Site Not Available

  • American Fork Hospital

    American Fork, Utah 84003
    United States

    Site Not Available

  • Logan Regional Hospital

    Logan, Utah 84321
    United States

    Site Not Available

  • Cottonwood Hospital Medical Center

    Murray, Utah 84107
    United States

    Site Not Available

  • McKay-Dee Hospital Center

    Ogden, Utah 84403
    United States

    Site Not Available

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah 84604
    United States

    Site Not Available

  • Dixie Regional Medical Center - East Campus

    Saint George, Utah 84770
    United States

    Site Not Available

  • Latter Day Saints Hospital

    Salt Lake City, Utah 84103
    United States

    Site Not Available

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah 84106
    United States

    Site Not Available

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