Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00462735|
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Cancer of the Pharynx Cancer of the Larynx Nose Neoplasms Paranasal Sinus Neoplasms Cancer of the Oral Cavity||Drug: Cetuximab Drug: Hydroxyurea Drug: Fluorouracil Procedure: radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Experimental: Advanced Head and Neck Cancer
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
250 mg/m2 on Day 1 after the first dose of radiation was administered to all patientsDrug: Hydroxyurea
500 mg orally every 12 hours with the morning dose administered 2 hours before radiationDrug: Fluorouracil
continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hoursProcedure: radiotherapy
Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.
Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.
- Llocoregional Recurrence [ Time Frame: 2 years ]Percentage of Participants with Loco-regional recurrence.
- Survival [ Time Frame: 2 years ]Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology
- Long- Term Toxicity [ Time Frame: 2 years ]Grade 3 toxicities events
- UW-QOLR: Quality of Life Score [ Time Frame: 2 years ]University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).
- Distant Metastases [ Time Frame: 2 years ]Percentage of participants who did not have distant control
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): NCT00462735
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Johnny Kao, MD||Icahn School of Medicine at Mount Sinai|