Phase 2
N=30
Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer
Head and Neck Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01566435 ↗Enrolled (actual)
30
Serious AEs
32.2%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site — 76.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- paclitaxel albumin-stabilized nanoparticle formulation (Drug); Cisplatin (Drug); Fluorouracil (Drug); Intensity modulated radiation therapy (Radiation); Cetuximab (Drug); Quality-of-life assessment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site |
76.7 | — |
| SECONDARY Percentage of Participants With Partial Response (PR) at Primary Tumor Site |
16.7 | — |
| SECONDARY Number of Participants Per Anatomic Tumor Response by CT Scan |
23; 5; 2 | — |
| SECONDARY Metabolic Tumor Responses as Measured by FDG-PET/CT |
3; 25; 1 | — |
| SECONDARY Overall Survival Rate |
93.0 | — |
| SECONDARY Adverse Events as Measured by Number of Participants That Experienced Each Common Adverse Event During ACF Induction Therapy |
9; 7; 11; 24; 2; 3 | — |
| SECONDARY Changes in Secreted Protein Acidic and Rich in Cysteine (SPARC) Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue |
— | — |
| SECONDARY Complete Response (CR) or Partial Response (PR) at Regional (Neck) Nodes as Measured by Clinical Exam |
19; 7 | — |
| SECONDARY Changes in Ki-67 Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue |
— | — |
| SECONDARY Disease-free Survival (DFS) Rate |
97.0 | — |
| SECONDARY Progression-free Survival (PFS) |
97 | — |
| SECONDARY Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Total Score |
109.7; 105.8; 74.2; 98.4; 107.4; 114.6 | — |
| SECONDARY Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) FACT-G Total Score |
83.8; 79.1; 62.3 | — |
| SECONDARY Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Trial Outcome Index (TOI) |
69.7; 62.3; 34.2 | — |
Summary
This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF) consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.
Eligibility Criteria
Inclusion Criteria
- Patient must have selected stage III or IVa/b head and neck squamous cell carcinoma (HNSCC); all patients must have T2-T4 primary tumors; (patients with T1 tumors will be excluded); although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible
- Patient must have disease at the oropharynx, hypopharynx, larynx, or oral cavity sub-sites
- Patient must have measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with CT scan
- Patient must be >= 18 years of age.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status = = 1500/mcL
- Platelets > 100,000/mcL
- Hemoglobin > 9.0 g/dL
- Total bilirubin = grade 1
Data sourced from ClinicalTrials.gov (NCT01566435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.