MedPath

Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
Procedure: conventional surgery
Radiation: radiation therapy
Registration Number
NCT00011999
Lead Sponsor
Radiation Therapy Oncology Group
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 chemotherapy with radiation therapy following surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.

Detailed Description

OBJECTIVES:

* Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck.

* Determine the disease-free and overall survival of patients treated with this regimen.

* Determine the acute and chronic toxicity of this regimen in these patients.

* Determine the patterns of failure in patients treated with this regimen.

OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Surgery, chemotherapy and radiation therapycisplatinEarly post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
Surgery, chemotherapy and radiation therapyconventional surgeryEarly post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
Surgery, chemotherapy and radiation therapyradiation therapyEarly post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
Surgery, chemotherapy and radiation therapypaclitaxelEarly post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
Primary Outcome Measures
NameTimeMethod
Patient tolerance of the treatment regimenFrom registration to end of treatment
Secondary Outcome Measures
NameTimeMethod
Frequency of grade 5 and acute non-hematologic grade 4 toxicityFrom start of induction chemotherapy to 90 days after start of radiation therapy
Frequency of other acute and late toxicityFrom start of induction chemotherapy to last follow-up
Local-regional controlFrom registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.
Disease-free survivalFrom registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years.
Overall survivalFrom registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.

Trial Locations

Locations (234)

University of Alabama at Birmingham Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

Comprehensive Cancer Institute of Huntsville

🇺🇸

Huntsville, Alabama, United States

Huntsville Hospital System

🇺🇸

Huntsville, Alabama, United States

MBCCOP - Gulf Coast

🇺🇸

Mobile, Alabama, United States

Alabama Oncology, LLC

🇺🇸

Montgomery, Alabama, United States

DCH Cancer Treatment Center

🇺🇸

Tuscaloosa, Alabama, United States

Foundation for Cancer Research and Education

🇺🇸

Phoenix, Arizona, United States

Mount Diablo Medical Center

🇺🇸

Concord, California, United States

City of Hope Comprehensive Cancer Center

🇺🇸

Duarte, California, United States

Saint Agnes Cancer Center

🇺🇸

Fresno, California, United States

Scroll for more (224 remaining)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.