Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx
Eligibility 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
Sites / Locations
- Algemeen Ziekenhuis Middelheim
- Universitair Ziekenhuis Antwerpen
- CHR de Besancon - Hopital Jean Minjoz
- Centre Regional Francois Baclesse
- Centre Hospitalier Universitaire de Dijon
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
- Centre Oscar Lambret
- Centre Hospitalier Regional et Universitaire de Lille
- CRLCC Nantes - Atlantique
- Centre Antoine Lacassagne
- Hopital Charles Nicolle
- Centre Alexis Vautrin
- Rambam Medical Center
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Ospedale Civile Monselice
- Azienda Ospedaliera "Santa Maria Degli Angeli"
- Vrije Universiteit Medisch Centrum
- Leiden University Medical Center
- Academisch Ziekenhuis Maastricht
- Centre Hospitalier Universitaire Vaudois