TriangleNCT00462735 · REGISTRY CONDITION SEARCH
Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2018-03-13
For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Age 18 years or older * Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma * No prior chemotherapy or radiotherapy * Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor * Karnofsky performance status of \>= 70% * Intact organ and bone marrow function * Obtained informed consent Exclusion Criteria: * Demonstration of metastatic disease (i.e. M1 disease). * Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea. * Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years. * Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment. * Incomplete healing from previous surgery * Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician. * Uncontrolled active infection unless curable with treatment of their cancer.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
- intervention Names
- Drug: Cetuximab
- Drug: Hydroxyurea
- Drug: Fluorouracil
- Procedure: radiotherapy
- label
- Advanced Head and Neck Cancer
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Advanced Head and Neck Cancer
- description
- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients
- name
- Cetuximab
- type
- DRUG
- arm Group Labels
- Advanced Head and Neck Cancer
- description
- 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation
- name
- Hydroxyurea
- type
- DRUG
- arm Group Labels
- Advanced Head and Neck Cancer
- description
- continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours
- name
- Fluorouracil
- type
- DRUG
- arm Group Labels
- Advanced Head and Neck Cancer
- description
- 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.
- name
- radiotherapy
- type
- PROCEDURE
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 33
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Percentage of Participants with Loco-regional recurrence.
- measure
- Llocoregional Recurrence
- time Frame
- 2 years
- description
- 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
- measure
- Survival
- time Frame
- 2 years
- secondary Outcomes
- description
- Grade 3 toxicities events
- measure
- Long- Term Toxicity
- time Frame
- 2 years
- description
- 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).
- measure
- UW-QOLR: Quality of Life Score
- time Frame
- 2 years
- description
- Percentage of participants who did not have distant control
- measure
- Distant Metastases
- time Frame
- 2 years
Full study description
- brief Summary
- For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
Source references
- references
- citation
- Kao J, Genden EM, Gupta V, Policarpio EL, Burri RJ, Rivera M, Gurudutt V, Som PM, Teng M, Packer SH. Phase 2 trial of concurrent 5-fluorouracil, hydroxyurea, cetuximab, and hyperfractionated intensity-modulated radiation therapy for locally advanced head and neck cancer. Cancer. 2011 Jan 15;117(2):318-26. doi: 10.1002/cncr.25374. Epub 2010 Sep 9.
- pmid
- 20830768
- type
- RESULT
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-1ce8ce1a7590fb666d0f
- requested nct id
- NCT00462735
- primary nct id
- NCT00462735
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
- payload sha256
- e5a7cc2f3abdc9c0908c61df3a38927c8c5e5787a08415d83e1c722973f56660
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-1ce8ce1a7590fb666d0f
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT00462735
- occurrences
- context exact
- NCT00462735
- end
- 11
- exact text
- NCT00462735
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Laryngeal Cancer
- query disease state id
- ds-laryngeal-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
- source file sha256
- fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
- source json pointer
- /studies/101/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 71ed4d72f10e0949908b4fe8dbcb4592f193b73299a261808e4e016e4ace260f
Preserved source evidence · Not medical advice