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Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx Clinical research trials and Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx. Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx  Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
For Condition: stage 2 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the larynx,stage 3 squamous cell carcinoma of the hypopharynx,stage 3 squamous cell carcinoma of the larynx
Status: Recruiting
Sponsor(s): EORTC Head and Neck Cancer Cooperative Group , EORTC Radiotherapy Cooperative Group
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 and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx. PURPOSE: Randomizedphase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.
Details: OBJECTIVES: - Compare relapse-free survival and larynx preservation in patients with resectable hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and fluorouracil and radiotherapy. - Compare the health-related quality of life in patients treated with these regimens. - Compare the cost-effectiveness of these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by performance status, disease site, tumor stage, node stage, and center. Patients are randomized to one of two treatment arms. Both groups may receive either conventional radiotherapy in single daily fractions, 5 days per week, for 7 weeks (option 1) or hyperfractionated radiotherapy in 2 daily fractions, 5 days per week, for 4-5 weeks (option 2), according to institutional policy. - Arm I: Patients receive cisplatin and fluorouracil every 3 weeks. Patients with a complete or partial response on day 42 receive 2 additional courses of chemotherapy followed by 7 weeks of radiotherapy beginning on day 80. After radiotherapy, patients with a complete remission enter follow-up; those with a partial remission proceed to surgery. Patients with stable or progressive disease proceed immediately to surgery with or without postoperative radiotherapy. - Arm II: Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses. Patients treated on radiotherapy option 1 are evaluated 2 months after completion of radiotherapy; those with a complete remission enter follow-up while all others proceed to surgery. Patients treated on option 2 are evaluated on day 42; those with a partial or complete response complete chemoradiotherapy and are then evaluated and treated like option 1 patients. Patients with stable or progressive disease on day 42 proceed to surgery with or without a third course of chemotherapy on week 7. Patients are followed every 3 months for 3 years and at least every 6 months thereafter. PROJECTED ACCRUAL: A total of 564 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven squamous cell carcinoma of the head and neck, including: - Stage III/IV cancer of the glottic or supraglottic larynx - Eligible T4 tumor defined as: - Bulging the valleculae - Bulging the hyothyroid membrane - Minimal thyroid cartilage invasion or suspicion of invasion on imaging - Stage II/III/IV cancer of the pyriform sinus or of the hypopharyngeal aspect of the aryepiglottic fold (with or without extension to postcricoid area) - No massive destruction of the thyroid cartilage - No continuity between primary tumor and a lymph node - Operable on first attempt (as assessed by head and neck surgeon) by classical total laryngectomy with or without partial pharyngectomy - No requirement for extended surgery (circumferential pharyngolaryngectomy) - No tumor suitable for partial (functional) surgery or requiring extended surgery that necessitates any kind of flap for closure - No N2c tumor unless no requirement for bilateral resection of internal jugular veins - Measurable or evaluable disease by panendoscopy and CT scan or MRI - Esophagoscopy required - Bronchofiberscopy recommended - No requirement for tracheotomy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - WHO 0-2 Hematopoietic: - WBC at least 4,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 times normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - No medical, psychological, or geographical condition that precludes study compliance - No serious nonmalignant systemic disease - No second malignancy except: - Carcinoma in situ of the cervix - Adequately treated nonmelanomatous skin cancer - No poor nutritional status unlikely to be restored to fair status within 3 weeks - No contraindication to CT scan or general anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy - No prior anticancer biologic therapy Chemotherapy - No prior anticancer chemotherapy Endocrine therapy - No prior anticancer endocrine therapy Radiotherapy - No prior anticancer radiotherapy Surgery - See Disease Characteristics Other - No other prior anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Jean-LouisLefebvre, , Centre Oscar Lambret
Centre Hospitalier Universitaire de Dijon *Recruiting*
Dijon, , 21033
France
Recruiting Contact Person 33-380-41-8141
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Contact Person 41-314-1111
Azienda Ospedaliera "Santa Maria Degli Angeli" *Recruiting*
Pordenone, , 33170
Italy
Recruiting Contact Person 39-434-39-9612
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Contact Person 33-383-59-8400
Centre Hospitalier Regional et Universitaire de Lille *Recruiting*
Lille, , 59037
France
Recruiting Contact Person 33-320-44-4255
CHR de Besancon - Hopital Jean Minjoz *Recruiting*
Besancon, , 25030
France
Recruiting Contact Person 33-381-66-8166
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-52-6911
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Contact Person 33-231-455-000
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Contact Person 31-387-6543
Rambam Medical Center *Recruiting*
Haifa, , 31096
Israel
Recruiting Contact Person 972-854-3013
CRLCC Nantes - Atlantique *Recruiting*
Nantes-Saint Herblain, , 44805
France
Recruiting Contact Person 33-240-679-900
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon, , 21079
France
Recruiting Contact Person 33-380-73-7500
Ospedale Civile Monselice *Recruiting*
Monselice, Padova, , 35043
Italy
Recruiting Contact Person 39-78-8318
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact person 32-821-3000
Hopital Charles Nicolle *Recruiting*
Rouen, , 76031
France
Recruiting Contact Person 33-235-08-8247
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp, , 2020
Belgium
Recruiting Contact Person 32-280-3111
Centre Oscar Lambret *Recruiting*
Lille, , 59020
France
Recruiting Contact Person 33-320-295-959
Centre Antoine Lacassagne *Recruiting*
Nice, , 06189
France
Recruiting Contact Person 33-492-03-1000
Vrije Universiteit Medisch Centrum *Recruiting*
Amsterdam, , 1007 MB
Netherlands
Recruiting Contact Person 31-444-4444
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Milano (Milan), , 20133
Italy
Recruiting Contact Person 39-239-0291
Additional Information:
Study ID Numbers: CDR0000065056; EORTC-24954
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002839
Other Stage 3 Squamous Cell Carcinoma Of The Hypopharynx Studies:
1. High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
2. Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Head and Neck Cancer
3. Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
4. Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
5. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
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Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
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