Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer (Paradigm Trial)



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:August 2004

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A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]


RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and
carboplatin, work in different ways to stop tumor cells from dividing so they stop growing
or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining
chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which
regimen of chemotherapy and radiation therapy is most effective in treating head and neck
cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens
of chemotherapy and radiation therapy in treating patients who have stage III or stage IV
head and neck cancer.


OBJECTIVES:

Primary

- Compare 3-year survival of patients with previously untreated stage III or IV squamous
cell carcinoma of the head and neck treated with induction chemotherapy comprising
docetaxel, cisplatin, and fluorouracil followed by radiotherapy and carboplatin or
docetaxel vs radiotherapy and cisplatin only.

Secondary

- Compare 2-year progression-free status in patients treated with these regimens.

- Compare 5-year survival of patients treated with these regimens.

- Compare 3- and 5-year progression-free survival of patients treated with these
regimens.

- Compare the complete response rate in patients treated with these regimens.

- Compare tumor site-specific survival in patients treated with these regimens.

- Compare functional organ preservation in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

- Correlate tissue and germline markers with response, local/regional control, and the
development of distant metastases in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive induction chemotherapy comprising docetaxel, cisplatin, and
fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a
pathologic complete response at the primary site and a clinical complete response in
the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once
daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site
(i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease
in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent
radiotherapy once or twice daily, 5 days a week, for 6 weeks.

- Arm II: Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent
radiotherapy once or twice daily, 5 days a week, for 6 weeks.

Quality of life is assessed at baseline and then at 3, 12, and 24 months.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1
year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck

- Stage III or IV* disease

- One of the following primary tumor sites:

- Oral cavity

- No mandible invasion

- Oropharynx

- Hypopharynx

- Larynx

- The following primary tumor sites are excluded:

- Nasal cavity

- Paranasal cavity

- Nasopharynx NOTE: *No evidence of distant metastases by chest x-ray,
abdominal ultrasound, or CT scan (for patients with liver function test
abnormalities) or bone scan (for patients with local symptoms)

- At least 1 uni- or bi-dimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- WHO 0-1

Life expectancy

- Not specified

Hematopoietic

- Neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 10 g/dL

Hepatic

- Bilirubin normal

- AST or ALT within eligibility range

- Alkaline phosphatase within eligibility range

Renal

- Creatinine clearance > 60 mL/min

Cardiovascular

- No unstable cardiac disease despite treatment

- No myocardial infarction within the past 6 months

Pulmonary

- No chronic obstructive pulmonary disease, defined as requiring hospitalization for
pneumonia or respiratory decompensation within the past year

- Obstruction caused by the tumor allowed

Neurologic

- No symptomatic peripheral neuropathy > grade 2

- No symptomatic altered hearing > grade 2

- No history of significant neurologic or psychiatric disorders, including dementia or
seizures

Other

- No active drug addiction, including alcohol, cocaine, or intravenous drugs within the
past 6 months

- No other malignancy within the past 5 years except adequately treated carcinoma in
situ of the cervix, basal cell or squamous cell skin cancer, or other cancer
curatively treated by surgery alone

- No active, clinically significant, uncontrolled infection

- No autoimmune disease requiring therapy

- No unhealed or clinically active peptic ulcer disease

- No hypercalcemia

- No other serious illness or medical condition

- No involuntary weight loss > 25% of body weight within the past 2 months

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- No prior organ transplantation

- No prior surgery for this cancer

- Biopsy allowed

Other

- More than 30 days since prior participation in another investigational study

- No other concurrent anticancer therapy
We found this trial at
14
sites
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450 Brookline Ave
Boston, Massachusetts 2215
(617) 632-3000
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Founded in 1997, Dana-Farber/Harvard Cancer Center (DF/HCC) was...
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Boston, MA
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1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
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Bronx, NY
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1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
(704) 355-2884
Blumenthal Cancer Center at Carolinas Medical Center As our patients wage their personal wars against...
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Charlotte, NC
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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Lebanon, NH
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660 S Euclid Ave #8100
Saint Louis, Missouri 63110
(314) 362-5196
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis The Alvin J. Siteman Cancer Center...
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Saint Louis, MO
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100 Campus Dr # 108
Scarborough, Maine 04074
(207) 396-7600
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Maine Center for Cancer Medicine...
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Scarborough, ME
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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1720 S. Bellaire Street Suite 701
Denver, Colorado 80222
(303) 777-2663
Colorado Cancer Research Program CCOP Colorado Cancer Research Program (CCRP) was established in 1983 and...
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Egleston, GA
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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Maywood, IL
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Newark, New Jersey 07103
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Newark, NJ
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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