Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer of the Larynx Cancer of the Nasal Cavity Cancer of the Oral Cavity Cancer of the Pharynx Paranasal Sinus Neoplasms

Keywords

Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx)Cancer of the Nasal Cavity and Paranasal Sinuses

Outcome Measures

Primary Outcomes (1)

Overall Survival: Time From Randomization to Death From Any Cause
Survival rates over 6 years.
Up to 6 years

Secondary Outcomes (12)

Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
Up to 6 years
Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
Up to 6 years

Study Arms (2)

Induction plus chemoradiotherapy

ACTIVE COMPARATOR

Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.

Drug: docetaxelDrug: cisplatinDrug: hydroxyureaDrug: fluorouracilProcedure: chemotherapyProcedure: radiotherapy

Chemoradiotherapy

ACTIVE COMPARATOR

Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.

Interventions

docetaxelDrug

75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)

ChemoradiotherapyInduction plus chemoradiotherapy

cisplatinDrug

75 mg/m2 on day 1

Induction plus chemoradiotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years or older
Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma

Sponsors & Collaborators

University of Chicago
Otherlead

Study Sites (26)

USC University of Southern California Keck School of Medicine

Los Angeles, California, 90033, United States

UM Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Northwestern University

Chicago, Illinois, 60611, United States

Rush University Medical Center

Chicago, Illinois, 60612, United States

The University of Chicago

Chicago, Illinois, 60637, United States

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Evanston Northwestern Healthcare

Evanston, Illinois, 60201, United States

MeSH Terms

Conditions

Pharyngeal NeoplasmsLaryngeal NeoplasmsParanasal Sinus Neoplasms

Interventions

DocetaxelCisplatinHydroxyureaFluorouracilDrug TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal Diseases

Results Point of Contact

Title: Dr. Ezra E.W. Cohen
Organization: UC San Diego Moores Cancer Center

Study Officials

Everett Vokes, M.D.
University of Chicago
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

285 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 7, 2005

Study Start

November 2004

Date type not reported

This date has not been verified as actual or estimated.

Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Induction plus chemoradiotherapy

Chemoradiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Induction plus chemoradiotherapy

Chemoradiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations