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NCT00268372

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

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cisplatin/RT alone

cisplatin and radiation therapy

Group Type ACTIVE_COMPARATOR

cisplatin

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

induction chemo followed by cisplatin/RT

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

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

docetaxel

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

surgery

Intervention Type PROCEDURE

Interventions

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cisplatin

Intervention Type DRUG

docetaxel

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

surgery

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Other Intervention Names

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platinol taxotere 5-FU

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David J. Adelstein, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Gregory T. Wolf, MD

Role: STUDY_DIRECTOR

University of Michigan Rogel Cancer Center

P. G. Shankar Giri, MD, MB, BS

Role: STUDY_CHAIR

Veterans Affairs Medical Center - Houston

Locations

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Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Veterans Affairs Medical Center - Hines

Hines, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Trinity Medical Center - East

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

West Suburban Center for Cancer Care

River Forest, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Bettendorf, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Site Status