Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00014118|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 7, 2015
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||May 2009|
- Organ preservation rate
- Feasibility and toxicity
- Utility of pre- and post-treatment organ function instruments
- Disease-free survival and patterns of failure
- Objective tumor response rate (complete and partial response)
- Changes in quality of life
- Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- - 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
- ECOG 0-2
- 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 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:
- Not specified
- No prior chemotherapy
- No concurrent amifostine
- Not specified
- No prior radiotherapy above the clavicles
- No prior surgery to the primary tumor except biopsy or debulking
- No concurrent experimental mucosal protectants
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): NCT00014118
|Study Chair:||Anthony J. Cmelak, MD||Vanderbilt-Ingram Cancer Center|
|Responsible Party:||Eastern Cooperative Oncology Group|
|Other Study ID Numbers:||
U10CA021115 ( U.S. NIH Grant/Contract )
|First Posted:||January 27, 2003 Key Record Dates|
|Last Update Posted:||October 7, 2015|
|Last Verified:||October 2015|
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action