18 and older, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Complete Response Rate at the Primary TumorPrimary· 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.
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
16
Clinical Partial Response Rate at the Primary TumorSecondary· 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.
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
14
Clinical Complete and Partial Response Rates to the Involved Regional NodesSecondary· 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.
Complete response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
11
Partial response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
7
Clinical Overall Complete and Partial Response RatesSecondary· 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.
Overall complete response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
13
Overall partial response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
17
Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET ScanSecondary· 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.
Complete response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
9
Partial response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
17
Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET ScanSecondary· 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.
Complete response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
9
Partial response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
14
Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST CriteriaSecondary· 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.
Complete response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
10
Partial response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
11
Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST CriteriaSecondary· 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.
Complete response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
7
Partial response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
12
Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST CriteriaSecondary· 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.
Overall complete response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
4
Overall partial response
Group
Value
95% CI
Induction Chemo + RT + Cisplatin or Cetuximab
14
Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CTSecondary· 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.
Complete Response
Group
Value
95% CI
Clinical Examination
53
CT Scan
33
FDG-PET/CT
32
Partial Response
Group
Value
95% CI
Clinical Examination
47
CT Scan
41
FDG-PET/CT
61
Stable Disease/Progressive Disease
Group
Value
95% CI
Clinical Examination
0
CT Scan
26
FDG-PET/CT
7
Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CTSecondary· 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
Complete Response
Group
Value
95% CI
Clinical Examination
61
CT Scan
30
FDG-PET/CT
36
Partial Response
Group
Value
95% CI
Clinical Examination
39
CT Scan
48
FDG-PET/CT
56
Stable Disease/Progressive Disease
Group
Value
95% CI
Clinical Examination
0
CT Scan
22
FDG-PET/CT
8
Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CTSecondary· 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
Complete Response
Group
Value
95% CI
Clinical Examination
43
CT Scan
14
FDG-PET/CT
24
Partial Response
Group
Value
95% CI
Clinical Examination
57
CT Scan
50
FDG-PET/CT
66
Stable Disease/Progressive Disease
Group
Value
95% CI
Clinical Examination
0
CT Scan
36
FDG-PET/CT
10
Adverse events — posted to ClinicalTrials.gov
Time frame: From time of consent through completion of induction chemotherapy..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase two trial will determine the tumor response rate at the primary site and at involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07284836 — Phase II Trial of Albumin-Bound Paclitaxel Combined With Nedaplatin (TP) Via Hepatic Arterial Infusion for Advanced Brea
· Phase 2
· recruiting
NCT05911308 — Abequolixron (RGX-104) and Durvalumab in Lung Cancer
· Phase 1
· terminated
NCT05631886 — Combination of CAR-DC Vaccine and ICIs in Malignant Tumors
· Phase 1
· recruiting
NCT05828381 — Envafolimab Combined With Abraxane and Cisplatinas as Neoadjuvant Treatment for Resectable Esophageal Cancer
· Phase 2
· unknown
NCT05631899 — CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors
· Phase 1
· active not recruiting
Other recruiting trials for Squamous Cell Carcinoma of the Head and Neck
Currently open trials in the same condition.
NCT07465276 — Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
· Phase 2
· recruiting
NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
· Phase 1
· recruiting
NCT06223568 — Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subject
· Phase 2
· recruiting
NCT05983133 — A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors
· Phase 1
· active not recruiting
NCT05208762 — A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
· Phase 1
· recruiting
Other Washington University School of Medicine trials
Trials by the same sponsor.
NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
· Phase 2
· not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer
· Phase 2
· not yet recruiting
NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)
· Phase 1
· not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
· not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 9 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00736944.