NCT00004226

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery in treating patients who have recurrent or second primary cancer of the head and neck following previous radiation therapy.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 4, 2013

Status Verified

July 1, 2004

First QC Date

January 28, 2000

Last Update Submit

December 3, 2013

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the oropharynxrecurrent metastatic squamous neck cancer with occult primary

Interventions

radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the mucosa, recurrent (primary and/or nodal), or a second primary (positive or negative nodal), of one of the following: * Oral cavity * Oropharynx * Hypopharynx * Larynx * Paranasal sinus * Neck disease of unknown origin * No distant metastases * No primary in the nasopharynx * Must have complete gross resection of disease * Must have positive final margins, soft tissue extension of primary, positive extracapsular extension of lymph node disease, or at least 4 positive nodes without extracapsular extension * Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length * At least 6 months since prior radiotherapy with an overlap volume of at least 45 Gy * No grade 3 or 4 toxicity for the following organ tissues: * RTOG grade 3 or 4 skin, subcutaneous tissue, larynx, joint, or RTOG grade 4 mucous membrane or bone from prior radiotherapy * Radiotherapy must begin within 6-12 weeks of surgery * Prior radiotherapy records must be available PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant * No history of invasive malignancy that would be expected to cause death within 3 years PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • James L. Pearlman, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2000

First Posted

January 27, 2003

Study Start

May 1, 2000

Last Updated

December 4, 2013

Record last verified: 2004-07

Locations

US(3)