Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00014118
- Lead Sponsor
- Eastern Cooperative 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 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.
- Detailed Description
OBJECTIVES:
* Determine the organ preservation rate in patients with stage III or IV squamous cell carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed by paclitaxel with concurrent radiotherapy.
* Determine the feasibility and toxicity of this regimen in these patients.
* Determine the utility of pre- and post-treatment organ function instruments on swallowing ability and voice quality in patients treated with this regimen.
* Determine the disease-free survival and patterns of failure of patients treated with this regimen.
* Determine the objective tumor response rate (complete and partial response) in these patients following treatment with 2 courses of induction therapy with paclitaxel and carboplatin.
* Determine changes in quality of life of patients treated with this regimen.
* Determine whether the presence of human papilloma virus infection and p-glycoprotein correlates with outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease site (larynx vs oropharynx).
Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on days 1 and 22. Within 28 days after completion of induction therapy, patients with responding or stable disease receive paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and radiotherapy once daily, 5 times weekly, for 7 weeks beginning on day 1.
Within 6-8 weeks after completion of therapy, patients who initially had bulky neck disease (N3) or who have residual palpable lymphadenopathy undergo surgical neck dissection. Patients with N1-N2 disease with complete response may also undergo neck dissection. Patients with initial complete response who recur at the primary site undergo surgical salvage.
Quality of life is assessed at baseline, after induction therapy, and at 3, 12, and 24 months after completion of all therapy.
Patients are followed at 6 weeks, 3 months, every 6-8 weeks for 1 year, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years thereafter.
PROJECTED ACCRUAL: A total of 110 patients (55 per stratum) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Organ preservation rate Feasibility and toxicity Changes in quality of life Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome Utility of pre- and post-treatment organ function instruments Disease-free survival and patterns of failure Objective tumor response rate (complete and partial response)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Mercy Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Watson Clinic, LLC
🇺🇸Lakeland, Florida, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
🇺🇸Niles, Illinois, United States
Hematology and Oncology Associates
🇺🇸Chicago, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Hematology Oncology Associates - Skokie
🇺🇸Skokie, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
🇺🇸Skokie, Illinois, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Aultman Cancer Center at Aultman Hospital
🇺🇸Canton, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
🇺🇸Sayre, Pennsylvania, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States