Trial · NCT00736944
Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer
NCT00736944, Phase 2, Completed, Washington University School of Medicine; results first posted 2014-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer. Trials, record NCT00736944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00736944
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer
- NCT number
- NCT00736944
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Abraxane, Cetuximab, Cetuximab, Cisplatin, 5-FU, Radiation (Post induction), Cisplatin, Cetuximab
- First posted
- 2008-08-18
- Last updated
- 2020-09-09
- Results first posted
- 2014-01-07
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Complete Response Rate at the Primary Tumor | post-2 cycles of induction (approximately 42 days from start of treatment) | All patients who completed 2 cycles of induction therapy. | participants | NUMBER |
| SECONDARY | Clinical Partial Response Rate at the Primary Tumor | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Participants who completed 2 cycles of induction therapy | participants | NUMBER |
| 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) | Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam. | participants | NUMBER |
| SECONDARY | Clinical Overall Complete and Partial Response Rates | post-2 cycles of induction therapy (approximately 42 days) | participants | NUMBER | |
| 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) | Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan. | participants | NUMBER |
| 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) | Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured. | participants | NUMBER |
| 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) | Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline. | participants | NUMBER |
| 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) | Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST. | participants | NUMBER |
| 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) | One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion. | participants | NUMBER |
| 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) | 2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease. | percentage of participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Complete Response Rate at the Primary Tumor | Induction Chemo + RT + Cisplatin or Cetuximab | 16 | participants | ||
| Clinical Partial Response Rate at the Primary Tumor | Induction Chemo + RT + Cisplatin or Cetuximab | 14 | participants | ||
| Clinical Complete and Partial Response Rates to the Involved Regional Nodes | Induction Chemo + RT + Cisplatin or Cetuximab | Complete response | 11 | participants | |
| Clinical Complete and Partial Response Rates to the Involved Regional Nodes | Induction Chemo + RT + Cisplatin or Cetuximab | Partial response | 7 | participants | |
| Clinical Overall Complete and Partial Response Rates | Induction Chemo + RT + Cisplatin or Cetuximab | Overall complete response | 13 | participants | |
| Clinical Overall Complete and Partial Response Rates | Induction Chemo + RT + Cisplatin or Cetuximab | Overall partial response | 17 | participants | |
| Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | Induction Chemo + RT + Cisplatin or Cetuximab | Complete response | 9 | participants | |
| Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | Induction Chemo + RT + Cisplatin or Cetuximab | Partial response | 17 | participants | |
| Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | Induction Chemo + RT + Cisplatin or Cetuximab | Complete response | 9 | participants | |
| Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | Induction Chemo + RT + Cisplatin or Cetuximab | Partial response | 14 | participants |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Induction Chemo + RT + Cisplatin or Cetuximab | 30 | |
| Induction | COMPLETED | Induction Chemo + RT + Cisplatin or Cetuximab | 29 | |
| Induction | NOT COMPLETED | Induction Chemo + RT + Cisplatin or Cetuximab | 1 | |
| Definitive Treatment | STARTED | Induction Chemo + RT + Cisplatin or Cetuximab | 29 | |
| Definitive Treatment | COMPLETED | Induction Chemo + RT + Cisplatin or Cetuximab | 28 | |
| Definitive Treatment | NOT COMPLETED | Induction Chemo + RT + Cisplatin or Cetuximab | 1 |
Source ClinicalTrials.gov
Adverse events67
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic reaction/hypersensitivity | Immune system disorders | Induction Chemo + RT + Cisplatin or Cetuximab | 2 | 30 | 2 |
| other | INR | Investigations | Induction Chemo + RT + Cisplatin or Cetuximab | 3 | 30 | 3 |
| other | PTT | Investigations | Induction Chemo + RT + Cisplatin or Cetuximab | 2 | 30 | 2 |
| other | Fatigue | General disorders | Induction Chemo + RT + Cisplatin or Cetuximab | 19 | 30 | 19 |
| other | Weight loss | Investigations | Induction Chemo + RT + Cisplatin or Cetuximab | 2 | 30 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Induction Chemo + RT + Cisplatin or Cetuximab | 11 | 30 | 11 |
| other | Rash:acneiform | Skin and subcutaneous tissue disorders | Induction Chemo + RT + Cisplatin or Cetuximab | 20 | 30 | 20 |
| other | Rash:penile (unconfirmed HSV) | Skin and subcutaneous tissue disorders | Induction Chemo + RT + Cisplatin or Cetuximab | 2 | 30 | 2 |
| other | Constipation | Gastrointestinal disorders | Induction Chemo + RT + Cisplatin or Cetuximab | 7 | 30 | 7 |
| other | Dental:teeth | Gastrointestinal disorders | Induction Chemo + RT + Cisplatin or Cetuximab | 2 | 30 | 2 |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Chemo + RT + Cisplatin or Cetuximab | ||
| Total, other adverse events | Induction Chemo + RT + Cisplatin or Cetuximab | 30 | 30 |
| Total, serious adverse events | Induction Chemo + RT + Cisplatin or Cetuximab | 19 | 30 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00736944
GET https://conductscience.org/api/trials/v1/NCT00736944/registered?page=2