Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer

Not Recruiting

Trial ID: NCT00014118


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.

Official Title

A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx

Stanford Investigator(s)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery



   - 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

      - 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 > 20 mm (2.0 cm) with
      conventional techniques or as > 10 mm (1.0 cm) with 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



   - 18 and over

Performance status

   - ECOG 0-2

Life expectancy

   - Not specified


   - Absolute neutrophil count at least 1,500/mm^3

   - Platelet count at least 100,000/mm^3


   - Not specified


   - Creatinine less than 3.0 mg/dL

   - Calcium normal


   - 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


   - 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

   - No other malignancy within the past 3 years except basal or squamous cell skin cancer
   or carcinoma in situ of the cervix


Biologic therapy

   - Not specified


   - No prior chemotherapy

   - No concurrent amifostine

Endocrine therapy

   - Not specified


   - No prior radiotherapy above the clavicles


   - No prior surgery to the primary tumor except biopsy or debulking


   - No concurrent experimental mucosal protectants


radiation: radiation therapy

drug: carboplatin

drug: paclitaxel

procedure: conventional surgery

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nancy Mori

New Trial Alerts

Receive email alerts when trials open to patients.