Completed

A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

cisplatin

+ radiation therapy

DrugRadiation
Who is being recruted

Carcinoma+5

+ Carcinoma, Squamous Cell

+ Neoplasms

Until 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2000
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: October 22, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2000

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the rate of local regional recurrence at one year in patients with advanced head and neck cancer treated with boost radiotherapy and cisplatin. II. Determine the feasibility of treatment delivery, patient tolerance, and acute and late toxicities in these patients on this regimen. III. Determine the overall survival, disease free survival, and distant relapse rates of these patients on this regimen. OUTLINE: Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days for 6 weeks, and cisplatin IV over 1-2 hours on days 1 and 22. Patients may undergo salvage surgery if biopsy proven cancer remains more than 3 months after treatment. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually until death. PROJECTED ACCRUAL: A total of 50-56 patients will be accrued for this study within 7 months.

NCT00005088
Principal SponsorRadiation Therapy Oncology Group
Last updated: October 22, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Squamous CellNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSquamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx Stage III or IV No distant metastases PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: At least 6 months Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Calcium normal Cardiovascular: No symptomatic coronary artery disease No angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No initial surgery (except diagnostic biopsy of the primary site or neck)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 258 locations

University of Alabama Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama Comprehensive Cancer Center in Google Maps

Comprehensive Cancer Institute of Huntsville

Huntsville, United States

Huntsville Hospital System

Huntsville, United States

Mobile Infirmary Medical Center

Mobile, United States
Completed258 Study Centers