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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00268372
• Other study ID #: CDR0000459847
• Secondary ID: S0427U10CA032102
• Status: Terminated
• Phase: Phase 3
• First received: December 21, 2005
• Last updated: October 3, 2012
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: October 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin

• docetaxel

• 5-fluorouracil

Procedure:
• surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	American Fork Hospital	American Fork	Utah
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	Veterans Affairs Medical Center - Hines	Hines	Illinois
United States	Community Oncology Group at Cleveland Clinic Cancer Center	Independence	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Borgess Medical Center	Kalamazooaa	Michigan
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	Southwest Medical Center	Liberal	Kansas
United States	St. Rita's Medical Center	Lima	Ohio
United States	Logan Regional Hospital	Logan	Utah
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Trinity Medical Center - East	Moline	Illinois
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	West Suburban Center for Cancer Care	River Forest	Illinois
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Saint Louis University Cancer Center	Saint Louis	Missouri
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	University Hospital - San Antonio	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Capital Health System Regional Cancer Center	Trenton	New Jersey
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Wesley Medical Center	Wichita	Kansas
United States	Wilson Medical Center	Wilson	North Carolina
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Cleveland Clinic - Wooster	Wooster	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 2 years		2 years	No
Secondary	Progression-free survival by FACT-HN CTCAE v 3.0 at 2 years		2 years	No
Secondary	Toxicity by CTCAE v 3.0 after induction chemotherapy or after chemotherapy and radiotherapy		after chemotherapy	Yes
Secondary	Incidence of surgical resection		after treatment	No
Secondary	Site of relapse		at relapse	No
Secondary	Quality of life by FACT-HN week 19 after first and second registration date (arm 1)		after first and second registrations	No