Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00006107|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Taxotere Procedure: Surgery Radiation: radiation therapy||Phase 1|
- Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy.
- Determine the toxicity of this treatment regimen in this patient population.
- Determine the efficacy of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks.
Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy.
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD.
Patients are followed monthly for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)|
|Actual Study Start Date :||July 14, 2000|
|Actual Primary Completion Date :||July 17, 2003|
|Actual Study Completion Date :||July 3, 2004|
Other Name: DocetaxelProcedure: Surgery Radiation: radiation therapy
- MTD of Taxotere [ Time Frame: 8 Weeks ]
- Dose Limiting Toxicity [ Time Frame: 8 Weeks ]
- Overall Response Rate [ Time Frame: 4-12 weeks post chemo/radiation therapy ]
- Tumor Resistance Predictors [ Time Frame: Up to 1 year post chemo/radiation therapy ]Tumor Biopsies and tissues
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): NCT00006107
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Roy B. Tishler, MD, PhD||Dana-Farber Cancer Institute|