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Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer Clinical research trials and Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer  Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
For Condition: stage 3 squamous cell carcinoma of the larynx,stage 3 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the larynx,stage 4 squamous cell carcinoma of the oropharynx
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx - No recurrent disease - No evidence of distant metastasis - Resectable disease, defined as follows: - High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall) - No extension to root of tongue (for disease of the base of tongue) - No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall) - No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall) - No trismus (for disease of the tonsil, soft palate, or pharyngeal wall) - No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis) - For disease of the supraglottis, glottis, or subglottis: - No base of the tongue invasion greater than 2 cm - No tumor extension through cartilage to involve strap muscles of the neck - No tumor fixation to prevertebral fascia - No involvement of the carotid artery - No fixed nodal disease with involvement of the deep neck - Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx - Measurable disease - Lesions accurately measured in at least one dimension as at least 10 mm by conventional techniques OR at least 20 mm by spiral CT scan - Cytologic or histologic evidence of neoplasm is needed for measurable disease restricted to a solitary lesion - No other concurrent head and neck neoplasms PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Not specified Renal - Creatinine less than 3.0 mg/dL - Calcium normal Cardiovascular - No significant cardiac disease - No uncontrolled hypertension - No unstable angina - No congestive heart failure - No myocardial infarction within the past year - No serious cardiac arrhythmias requiring medication Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study completion - No significant detectable infection - No history of allergy to drugs containing Cremophor EL - No history of allergy to mammalian cell-derived products (epoetin alfa) or human albumin - No other malignancy within the past 3 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy - No concurrent amifostine Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy above the clavicles Surgery - No prior surgery to the primary tumor except biopsy or debulking Other - No concurrent experimental mucosal protectants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
A.J.Cmelak, Study Chair, Vanderbilt-Ingram Cancer Center
Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto, California, 94304-1290
United States
Recruiting Harlan Pinto 650-493-5000 ext. 4948
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5216
United States
Recruiting Harlan Pinto 650-725-9057
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting George Adams 612-625-2410
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6838
United States
Recruiting Barbara Murphy 615-936-1782
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting John Ridge 215-728-3517
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Arlene Forastiere 410-955-9818
Additional Information:
Study ID Numbers: CDR0000068468; ECOG-2399
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014118
Other Stage 4 Squamous Cell Carcinoma Of The Larynx Studies:
1. High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
2. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth, Pharynx, or Larynx
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
5. Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
Related Studies:
Other stage 4 squamous cell carcinoma of the larynx Clinical Trials
Other Tennessee Clinical Trials
Other Nashville Clinical Trials
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
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