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

NCT00268372 | Terminated Phase 3 DMC

• 3 other identifiers: CDR0000459847S0427U10CA032102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 74

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.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

• Survival at 2 years

  2 years

Secondary Outcomes (5)

• Progression-free survival by FACT-HN CTCAE v 3.0 at 2 years

  2 years

• Toxicity by CTCAE v 3.0 after induction chemotherapy or after chemotherapy and radiotherapy

  after chemotherapy

• Incidence of surgical resection

  after treatment

• Site of relapse

  at relapse

• Quality of life by FACT-HN week 19 after first and second registration date (arm 1)

  after first and second registrations

Study Arms (2)

cisplatin/RT alone

ACTIVE COMPARATOR

cisplatin and radiation therapy

Drug: cisplatin; Radiation: radiation therapy

induction chemo followed by cisplatin/RT

EXPERIMENTAL

docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by surgery and/or cisplatin and radiation therapy

Drug: cisplatin; Drug: docetaxel; Drug: 5-fluorouracil; Procedure: surgery

Interventions

cisplatin DRUG

Also known as: platinol

cisplatin/RT alone; induction chemo followed by cisplatin/RT

docetaxel DRUG

Also known as: taxotere

induction chemo followed by cisplatin/RT

5-fluorouracil DRUG

Also known as: 5-FU

induction chemo followed by cisplatin/RT

surgery PROCEDURE

induction chemo followed by cisplatin/RT

radiation therapy RADIATION

cisplatin/RT alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (74)

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612-3785, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Trinity Medical Center - East

Moline, Illinois, 61265, United States

Location

Unknown Facility

Moline, Illinois, 61265, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Unknown Facility

Bettendorf, Iowa, 52722, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Capital Health System Regional Cancer Center

Trenton, New Jersey, 08618, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Lenoir Memorial Cancer Center

Kinston, North Carolina, 28501, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78209, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

University Hospital - San Antonio

San Antonio, Texas, 78229, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84103, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Docetaxel; Fluorouracil; Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• David J. Adelstein, MD

  The Cleveland Clinic

  STUDY CHAIR

• Gregory T. Wolf, MD

  University of Michigan Rogel Cancer Center

  STUDY DIRECTOR

• P. G. Shankar Giri, MD, MB, BS

  Veterans Affairs Medical Center - Houston

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 22, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

US (74)