Trial · NCT00736944
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Complete Response Rate at the Primary Tumor | post-2 cycles of induction (approximately 42 days from start of treatment) | Clinical exam included laryngoscopy in office or operating room. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. |
| Secondary | Clinical Partial Response Rate at the Primary Tumor | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Clinical exam included laryngoscopy in office or operating room. Partial response rate (PR) defined as 50% to 94% decrease in tumor size. |
| Secondary | Clinical Complete and Partial Response Rates to the Involved Regional Nodes | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. |
| Secondary | Clinical Overall Complete and Partial Response Rates | post-2 cycles of induction therapy (approximately 42 days) | Clinical exam included laryngoscopy in office or operating room. Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. |
| Secondary | Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. |
| Secondary | Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. |
| Secondary | Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. |
| Secondary | Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. |
| Secondary | Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. |
| Secondary | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles. |
| Secondary | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. |
| Secondary | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. |
| Secondary | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields |
| Secondary | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields |
| Secondary | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = intensity of SPARC staining in tumor |
| Secondary | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = intensity of SPARC staining in tumor |
| Secondary | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | completion of the first 10 patients induction chemotherapy | |
| Secondary | Overall Survival | 10 years from completion of treatment | Time from diagnosis to death or to last follow-up alive. |
| Secondary | Disease Free Survival | 10 years from completion of treatment | Time from complete response to death from any cause, to disease progression or to last follow-up alive. |
| Secondary | Time to Progression | 10 years from completion of treatment | Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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