Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
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|ClinicalTrials.gov Identifier: NCT00014118|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 7, 2015
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
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|