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

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ClinicalTrials.gov Identifier: NCT00268372
Recruitment Status : Terminated (SWOG eliminated its head and neck committee)
First Posted : December 22, 2005
Last Update Posted : October 4, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief 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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cisplatin Drug: docetaxel Drug: 5-fluorouracil Procedure: surgery Radiation: radiation therapy Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: cisplatin/RT alone
cisplatin and radiation therapy
Drug: cisplatin
Other Name: platinol

Radiation: radiation therapy
Experimental: induction chemo followed by cisplatin/RT
docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by surgery and/or cisplatin and radiation therapy
Drug: cisplatin
Other Name: platinol

Drug: docetaxel
Other Name: taxotere

Drug: 5-fluorouracil
Other Name: 5-FU

Procedure: surgery



Primary Outcome Measures :
  1. Survival at 2 years [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression-free survival by FACT-HN CTCAE v 3.0 at 2 years [ Time Frame: 2 years ]
  2. Toxicity by CTCAE v 3.0 after induction chemotherapy or after chemotherapy and radiotherapy [ Time Frame: after chemotherapy ]
  3. Incidence of surgical resection [ Time Frame: after treatment ]
  4. Site of relapse [ Time Frame: at relapse ]
  5. Quality of life by FACT-HN week 19 after first and second registration date (arm 1) [ Time Frame: after first and second registrations ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268372


  Hide Study Locations
Locations
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Trinity Medical Center - East
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
Bettendorf, Iowa, United States, 52722
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, New Jersey
Capital Health System Regional Cancer Center
Trenton, New Jersey, United States, 08618
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Logan Regional Hospital
Logan, Utah, United States, 84321
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84103
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: David J. Adelstein, MD The Cleveland Clinic
Study Director: Gregory T. Wolf, MD University of Michigan Cancer Center
Study Chair: P. G. Shankar Giri, MD, MB, BS Veterans Affairs Medical Center - Houston

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00268372     History of Changes
Other Study ID Numbers: CDR0000459847
S0427 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Southwest Oncology Group:
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs