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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Head and Neck Cancer
Interventions:	Drug: carboplatin; Drug: cisplatin; Drug: docetaxel; Drug: fluorouracil

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between August 24, 2004 and December 29, 2008 145 patients were enrolled across 16 sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomly assigned in a 1:1 ratio to recieve either induction chemotherapy with 3 cycles of TPF followed by concurrent chemoradiotherapy with either docetaxel or carboplatin or concurrent chemoradiotherapy alone with 2 cycles of bolus cisplatin.

Reporting Groups

	Description
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. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks carboplatin : Given IV fluorouracil : Given IV docetaxel : Given IV
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. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks

Participant Flow:   Overall Study

	Arm I	Arm II
STARTED	70	75
COMPLETED	56	66
NOT COMPLETED	14	9

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks carboplatin : Given IV fluorouracil : Given IV docetaxel : Given IV
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. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
Total	Total of all reporting groups

Baseline Measures

	Arm I	Arm II	Total
Overall Participants Analyzed; [Units: Participants]	70	75	145
Age; [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	59	66	125
>=65 years	11	9	20
Age; [Units: Years]; Mean (Standard Deviation)	55 (9)	54 (8)	55 (8.4)
Gender; [Units: Participants]
Female	6	12	18
Male	64	63	127
Region of Enrollment; [Units: Participants]
United States	69	69	138
Germany	1	6	7

  Outcome Measures

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1. Primary:

Overall Survival [ Time Frame: 3-years ]

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2. 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 [ Time Frame: 5 years ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  

Name/Title: Robert I Haddad, MD
Organization: Dana Farber Cancer Institute
phone: 617-632-3090
e-mail: rihaddad@partners.org

Publications of Results:

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.

Responsible Party:	Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00095875 History of Changes
Obsolete Identifiers:	NCT00705068
Other Study ID Numbers:	DFCI 04-006; P30CA006516 ( U.S. NIH Grant/Contract ); CDR0000393548 ( Registry Identifier: NCI PDQ )
First Submitted:	November 9, 2004
First Posted:	November 9, 2004
Results First Submitted:	May 15, 2013
Results First Posted:	July 2, 2013
Last Update Posted:	November 19, 2013