TriangleNCT00352105 · STUDY IN CONTEXT
Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.
Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.
Any toxicity greater than or equal to Grade 1= mild
Complete response rate per RECIST Criteria (CTC V3)
Number of Participants Who Completed 2 Years of Therapy
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- trial label
- Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0000
- source section id
- NCT00352105-om-0000
- source outcome index
- 0
- endpoint
- Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival
- endpoint definition
- To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
- time origin
- at 1 year after start of treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0005
- source section id
- NCT00352105-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With No Distant Metastatic Disease at 1 Year
- endpoint definition
- 1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.
- time origin
- 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 5 early deaths were not evaluable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0001
- source section id
- NCT00352105-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With No Local Disease at 1 Year
- endpoint definition
- Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.
- time origin
- at 1 year after start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 5 early deaths not evaluable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0002
- source section id
- NCT00352105-om-0002
- source outcome index
- 2
- endpoint
- Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity
- endpoint definition
- Any toxicity greater than or equal to Grade 1= mild
- time origin
- at 1 year after start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0003
- source section id
- NCT00352105-om-0003
- source outcome index
- 3
- endpoint
- Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.
- endpoint definition
- Complete response rate per RECIST Criteria (CTC V3)
- time origin
- 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 5 early deaths were not evaluable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0004
- source section id
- NCT00352105-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants Who Completed 2 Years of Therapy
- endpoint definition
- Number of Participants Who Completed 2 Years of Therapy
- time origin
- at 2 years after start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 5-FU, Cisplatin, Radiation and Iressa
- regimen
- Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 60
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352105-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 5-FU, Cisplatin, Radiation and Iressa
- regimen
- Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352105-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 5-FU, Cisplatin, Radiation and Iressa
- regimen
- Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 60
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352105-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0003
- arm key
- OG000
- arm label
- 5-FU, Cisplatin, Radiation and Iressa
- regimen
- Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352105-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0004
- arm key
- OG000
- arm label
- 5-FU, Cisplatin, Radiation and Iressa
- regimen
- Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 60
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352105-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- outcome key
- om-0005
- arm key
- OG000
- arm label
- 5-FU, Cisplatin, Radiation and Iressa
- regimen
- Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00352105-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00352105
- harm key
- EG000
- source section id
- NCT00352105-ae
- event group key
- EG000
- event group label
- 5-FU, Cisplatin, Radiation and Iressa
- serious affected
- 60
- serious at risk
- 60
- other affected
- 55
- other at risk
- 60
- frequency threshold
- 5
- collection period
- For 2 years of the study
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice