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

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00268372

Purpose

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	Intervention	Phase
Head and Neck Cancer	Drug: cisplatin Drug: docetaxel Drug: fluorouracil Procedure: conventional surgery Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Cisplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Survival at 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival by FACT-HN CTCAE v 3.0 at 2 years [ Designated as safety issue: No ]
Toxicity by CTCAE v 3.0 after induction chemotherapy or after chemotherapy and radiotherapy [ Designated as safety issue: Yes ]
Incidence of surgical resection [ Designated as safety issue: No ]
Site of relapse [ Designated as safety issue: No ]
Quality of life by FACT-HN week 19 after first and second registration date (arm 1) [ Designated as safety issue: No ]

Estimated Enrollment:	398
Study Start Date:	December 2005
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268372

Show 74 Study Locations

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence H. Baker, D.O., Southwest Oncology Group-Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00268372 History of Changes
Other Study ID Numbers:	CDR0000459847, S0427, U10CA032102
Study First Received:	December 21, 2005
Last Updated:	July 21, 2011
Health Authority:	United States: Federal Government

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:

Neoplasms, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel

Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012