Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
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|ClinicalTrials.gov Identifier: NCT00002839|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 8, 2013
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: Randomized phase 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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||564 participants|
|Official Title:||PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS|
|Study Start Date :||July 1996|
|Primary Completion Date :||May 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002839
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|CHR de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Hospitalier Universitaire de Dijon|
|Dijon, France, 21033|
|Centre de Lutte Contre le Cancer, Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Hospitalier Regional et Universitaire de Lille|
|Lille, France, 59037|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Hopital Charles Nicolle|
|Rouen, France, 76031|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Milano (Milan), Italy, 20133|
|Ospedale Civile Monselice|
|Monselice, Padova, Italy, 35043|
|Azienda Ospedaliera "Santa Maria Degli Angeli"|
|Pordenone, Italy, 33170|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1007 MB|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Study Chair:||Jean-Louis Lefebvre, MD||Centre Oscar Lambret|
|Study Chair:||Jean-Claude Horiot, MD, PhD||Centre Georges Francois Leclerc|