Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)
A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]
3 other identifiers
interventional
145
2 countries
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 head-and-neck-cancer
Started Aug 2004
Typical duration for phase_3 head-and-neck-cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2004
CompletedFirst Posted
Study publicly available on registry
November 9, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
July 2, 2013
CompletedNovember 19, 2013
October 1, 2013
7.7 years
November 9, 2004
May 15, 2013
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
5 years
Study Arms (2)
Arm I
EXPERIMENTALPatients 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
EXPERIMENTALPatients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +54 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (15)
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, 33486, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, 04074, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002, United States
UMDNJ University Hospital
Newark, New Jersey, 07103, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Klinikum der J.W. Goethe Universitaet
Frankfurt, D-60590, Germany
Related Publications (1)
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 chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013 Mar;14(3):257-64. doi: 10.1016/S1470-2045(13)70011-1. Epub 2013 Feb 13.
PMID: 23414589RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert I Haddad, MD
- Organization
- Dana Farber Cancer Institute
Study Officials
- STUDY CHAIR
Robert I. Haddad, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncology
Study Record Dates
First Submitted
November 9, 2004
First Posted
November 9, 2004
Study Start
August 1, 2004
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
November 19, 2013
Results First Posted
July 2, 2013
Record last verified: 2013-10