Head and Neck Cancer Clinical Trial
Official title:
A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]
Verified date | October 2013 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
List of Inclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum der J.W. Goethe Universitaet | Frankfurt | |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton | Florida |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York |
United States | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina |
United States | CCOP - Colorado Cancer Research Program | Denver | Colorado |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | UMDNJ University Hospital | Newark | New Jersey |
United States | UPMC Cancer Centers | Pittsburgh | Pennsylvania |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | National Cancer Institute (NCI) |
United States, Germany,
Haddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, Clark J, Sarlis N, Lorch J, Beitler JJ, Limaye S, Riley S, Posner M. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemorad — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival | 3-years | No |
Secondary | Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years | Progression free survival was defined as the time from date of randomisation to disease progression or death from any cause without progression whichever occurred first; otherwise, patients were censored at the date last known to be free of progression. | 5 years | No |
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