Trial · NCT02573493
Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
NCT02573493, Phase 2, Completed, Washington University School of Medicine; results first posted 2021-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC). Trials, record NCT02573493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02573493
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
- NCT number
- NCT02573493
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell of the Head and Neck, Cancer of Head and Neck, Cancer of the Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck
- Interventions
- nab-Paclitaxel, Cisplatin, Cetuximab, Intensity-Modulated Radiation Therapy
- First posted
- 2015-10-09
- Last updated
- 2024-12-27
- Results first posted
- 2021-03-02
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Completion of 2 cycles (approximately 6 weeks) | * Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note. * Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality |
| Primary | Arm 3: Median Percent Weight Loss | Completion of treatment (estimated to be 11-15 weeks) | |
| Secondary | Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Completion of 2 cycles (approximately 6 weeks) | * Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ENT physician's clinical exam note. * Partial response - 99-50% decrease |
| Secondary | Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Completion of 2 cycles (approximately 6 weeks) | * The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note. * Complete response - complete resolution - 100% decrease/minimal residual mucosal abnormality |
| Secondary | Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Completion of 2 cycles (approximately 6 weeks) | * The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note. * Partial response - 99%-50% decrease |
| Secondary | Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria | Completion of 2 cycles (approximately 6 weeks) | -Computed tomography (CT) scan (intravenous contrast preferred) to document and measure the extent of the primary tumor size and involved regional neck nodes. RECIST 1.1 will be used to determine response at the primary tumor site, at the involved regional neck nodes and the radiographic overall tumor response. |
| Secondary | Arms 1, 2, and 3: Document and Quantify Ki-67 Expression by IHC in Primary Tumor Tissue and Correlate With Clinical Primary Tumor Site Response | Completion of 2 cycles (approximately 6 weeks) | |
| Secondary | Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | 30 days after completion of treatment (estimated to be 15-25 weeks) | Compare to those observed with APF with the objective that Arm 1 will be at least 25% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 30%) and Arm 2 will be at least 50% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 20%). |
| Secondary | Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4 | Baseline and one year after completion of treatment (approximately 74 weeks) | -The FACT/GOG-NTX-4 questionnaire has 4 questions about neuropathy (numbness/tingling in hands/feet and discomfort in hands/feet) with answers ranging from 0 (Not at all) to 4 (Very Much). The total score ranges from 0 to 16. A lower score indicates less neuropathy symptoms. |
| Secondary | Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N | Baseline and one year after completion of treatment (approximately 74 weeks) | -The FACT-H\&N has 5 domains with 39 items including physical well-being (PWB), social/family well being (SWB), emotional well-being (EWB), functional well-being (FWB), and head \& neck cancer (HNCS) with answers ranging from 0 (Not at all) to 4 (Very Much). The PWB subscale score ranges from 0-28. The SWB subscale score ranges from 0-28. The EWB subscale score ranges from 0-24. The FWB subscale score ranges from 0-28. The HNCS subscale score ranges from 0-40. To obtain the total score all subscales are added together. The total score ranges from 0-148 with a higher score indicating a better quality of life. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Completion of 2 cycles (approximately 6 weeks) | Only participants enrolled in Arm 1 and Arm 2 are evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Arm 3: Median Percent Weight Loss | Completion of treatment (estimated to be 11-15 weeks) | Only participants enrolled in Arm 3 are evaluable for this outcome measure. | percentage of weight loss | MEDIAN |
| SECONDARY | Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Completion of 2 cycles (approximately 6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Completion of 2 cycles (approximately 6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Completion of 2 cycles (approximately 6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria | Completion of 2 cycles (approximately 6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Arms 1, 2, and 3: Document and Quantify Ki-67 Expression by IHC in Primary Tumor Tissue and Correlate With Clinical Primary Tumor Site Response | Completion of 2 cycles (approximately 6 weeks) | The data was not collected for this outcome measure. | ||
| SECONDARY | Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | 30 days after completion of treatment (estimated to be 15-25 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4 | Baseline and one year after completion of treatment (approximately 74 weeks) | score on a scale | MEAN | |
| SECONDARY | Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N | Baseline and one year after completion of treatment (approximately 74 weeks) | score on a scale | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 28 | Participants | ||
| Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Arm 2: Nab-Paclitaxel (A) + CRT | 8 | Participants | ||
| Arm 3: Median Percent Weight Loss | Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 6.7 | Full Range 2.2 to 12.9 | percentage of weight loss | |
| Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 11 | Participants | ||
| Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Arm 2: Nab-Paclitaxel (A) + CRT | 28 | Participants | ||
| Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site | Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 6 | Participants | ||
| Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 18 | Participants | ||
| Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Arm 2: Nab-Paclitaxel (A) + CRT | 14 | Participants | ||
| Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 3 | Participants | ||
| Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes | Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 11 | Participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 40 | |
| Overall Study | STARTED | Arm 2: Nab-Paclitaxel (A) + CRT | 40 | |
| Overall Study | STARTED | Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 15 | |
| Overall Study | STARTED | Not Enrolled in Any Arm | 1 | |
| Overall Study | COMPLETED | Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 40 | |
| Overall Study | COMPLETED | Arm 2: Nab-Paclitaxel (A) + CRT | 40 | |
| Overall Study | COMPLETED | Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 15 | |
| Overall Study | COMPLETED | Not Enrolled in Any Arm | 0 | |
| Overall Study | NOT COMPLETED | Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 0 | |
| Overall Study | NOT COMPLETED | Arm 2: Nab-Paclitaxel (A) + CRT | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,475
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 | Atrial fibrillation | Cardiac disorders | Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction | 1 | 40 | |
| other | Atrial fibrillation | Cardiac disorders | Arm 2: Nab-Paclitaxel (A) Induction | 3 | 40 | |
| other | Atrial fibrillation | Cardiac disorders | Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction | 1 | 15 | |
| other | Atrial fibrillation | Cardiac disorders | Arm 1 CRT: Cisplatin + Radiation Therapy | 0 | 34 | |
| other | Atrial fibrillation | Cardiac disorders | Arm 1 & 2 ERT: Cetuximab + Radiation Therapy | 4 | 42 | |
| other | Atrial fibrillation | Cardiac disorders | Arm 3 CR: Cisplatin + Radiation Therapy | 1 | 15 | |
| other | Atrial fibrillation | Cardiac disorders | Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up | 0 | ||
| other | Atrial fibrillation | Cardiac disorders | Arm 2: Nab-Paclitaxel + ERT Follow-up | 0 | ||
| other | Atrial fibrillation | Cardiac disorders | Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up | 0 | ||
| other | Cardiac ischemia/infarction | Cardiac disorders | Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction | 2 | 40 |
1 to 10 of 2,475Source ClinicalTrials.gov
See all 2,475 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction | 0 | 40 |
| Total, all-cause mortality | Arm 2: Nab-Paclitaxel (A) Induction | 0 | 40 |
| Total, all-cause mortality | Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction | 0 | 15 |
| Total, all-cause mortality | Arm 1 CRT: Cisplatin + Radiation Therapy | 0 | 34 |
| Total, all-cause mortality | Arm 1 & 2 ERT: Cetuximab + Radiation Therapy | 0 | 42 |
| Total, all-cause mortality | Arm 3 CR: Cisplatin + Radiation Therapy | 0 | 15 |
| Total, all-cause mortality | Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up | 9 | 40 |
| Total, all-cause mortality | Arm 2: Nab-Paclitaxel + ERT Follow-up | 21 | 40 |
| Total, all-cause mortality | Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up | 4 | 15 |
| Total, other adverse events | Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction | 40 | 40 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33683482 | DERIVED |
Source PubMed
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.
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