Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth, Pharynx, or Larynx
Recruitment status was Active, not recruiting
|First Received Date ICMJE||December 10, 1999|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||August 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00004094 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth, Pharynx, or Larynx|
|Official Title ICMJE||A Phase II Study of Induction Chemotherapy Followed by Concomitant Paclitaxel (1 Hour Infusion), Fluorouracil, Hydroxyurea and Hyperfractionated Radiotherapy for Advanced Oral, Pharynx and Larynx Cancer|
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 radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated advanced cancer of the mouth, pharynx, or larynx.
OUTLINE: Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes weekly for 3 weeks. Treatment repeats every 4 weeks for 2 courses.
At 1-2 weeks after completion of induction chemotherapy, patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, radiotherapy twice daily on days 1-5, and paclitaxel IV over 1 hour on day 2. Treatment repeats every 2 weeks for 5 courses.
Patients with residual nodal disease or initially staged nodal disease in the absence of macroscopic residual disease undergo neck dissection after completion of chemoradiotherapy. Patients with residual disease at the primary site undergo complete excision of disease. Patients with disease progression or disease recurrence are considered for conventional surgical management.
Quality of life is assessed every 3 months for 6 months, every 6 months for 1.5 years, and then annually thereafter.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 12-18 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Head and Neck Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||15 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00004094|
|Other Study ID Numbers ICMJE||CDR0000067310, NU-C98N1, UCCRC-9502, NCI-G99-1587|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Robert H. Lurie Cancer Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||December 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP