NCT00002951

Brief Summary

RATIONALE: Drugs used in chemotherapy use 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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 1996

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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

June 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

8 years

First QC Date

November 1, 1999

Last Update Submit

September 4, 2013

Conditions

Esophageal CancerHead and Neck Cancer

Keywords

stage II esophageal cancerstage III esophageal cancerstage II nasopharyngeal cancerstage III nasopharyngeal cancerstage II lip and oral cavity cancerstage III lip and oral cavity cancerstage II hypopharyngeal cancerstage III hypopharyngeal cancerstage II laryngeal cancerstage III laryngeal cancerstage II paranasal sinus and nasal cavity cancerstage III paranasal sinus and nasal cavity cancerstage II oropharyngeal cancerstage III oropharyngeal cancer

Outcome Measures

Primary Outcomes (1)

  • Locoregional control rate

    8 years

Study Arms (1)

Arm A (Hyper-FHX)

EXPERIMENTAL

Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)

Drug: fluorouracilDrug: hydroxyureaProcedure: surgical procedureRadiation: radiation therapy

Interventions

fluorouracilDRUG
Arm A (Hyper-FHX)
hydroxyureaDRUG
Arm A (Hyper-FHX)
surgical procedurePROCEDURE
Arm A (Hyper-FHX)
radiation therapyRADIATION
Arm A (Hyper-FHX)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed diagnosis of carcinoma * Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus * No N2 or N3 * Measurable disease is not required PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-3 Life expectancy: * Anticipated survival is 3-4 years (median) Hematopoietic: * WBC count at least 3.5/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * Not specified Pulmonary: * Not specified Other: * No infection or severe medical illness * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * No prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

Related Publications (1)

  • Cohen EE, Haraf DJ, List MA, Kocherginsky M, Mittal BB, Rosen F, Brockstein B, Williams R, Witt ME, Stenson KM, Kies MS, Vokes EE. High survival and organ function rates after primary chemoradiotherapy for intermediate-stage squamous cell carcinoma of the head and neck treated in a multicenter phase II trial. J Clin Oncol. 2006 Jul 20;24(21):3438-44. doi: 10.1200/JCO.2006.05.8529.

    PMID: 16849759RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsHead and Neck NeoplasmsNasopharyngeal NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsOropharyngeal Neoplasms

Interventions

FluorouracilHydroxyureaSurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesOrganic ChemicalsTherapeutics

Study Officials

  • Everett E. Vokes, MD

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1996

Primary Completion

June 1, 2004

Study Completion

July 1, 2006

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(4)