Related Experiment Video
Updated: Jan 22, 2026

Porcine As a Training Module for Head and Neck Microvascular Reconstruction
Published on: September 29, 2018
Window of opportunity trials in head and neck cancer
Janice L Farlow1, Andrew C Birkeland2, Paul L Swiecicki3,4
1Department of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, MI 48109, USA.
Abstract:
Head and neck squamous cell carcinoma (HNSCC) has a large global burden of disease and poor survival outcomes. Recent targeted therapies and immunotherapies have been explored in HNSCC, but there has been limited translation to clinical practice outside of recurrent or metastatic cases. Window of opportunity settings, where novel agents are administered between cancer diagnosis and planned definitive therapy, have begun to be employed in HNSCC. Tumor tissue biopsies are obtained at diagnosis and after the investigation treatment, along with other biospecimens and radiographic exams. Thus, this study design can characterize the safety profiles, pharmacodynamics, and initial tumor responses to novel therapies in a treatment-naïve subject. Early window studies have also identified potential biomarkers to predict sensitivity or resistance to treatments. However, these early investigations have revealed multiple challenges associated with this trial design. In this review, we discuss recent window of opportunity trials in HNSCC and how they inform design considerations for future studies.
Insights
Window of opportunity trials in head and neck squamous cell carcinoma (HNSCC) offer insights into novel therapies. This review examines challenges and design considerations for future HNSCC early window studies.
Area of Science:
- Oncology
- Clinical Trials
- Cancer Therapeutics
Background:
- Head and neck squamous cell carcinoma (HNSCC) presents significant global health challenges with poor survival rates.
- Current targeted and immunotherapies show limited clinical application beyond recurrent or metastatic HNSCC.
- Early window studies are emerging as a strategy to evaluate novel agents in treatment-naïve HNSCC patients.
Purpose of the Study:
- To review recent window of opportunity trials in HNSCC.
- To discuss the challenges encountered in these early investigations.
- To inform the design considerations for future HNSCC early window studies.
Main Methods:
- Review of recent literature on window of opportunity trials in HNSCC.
- Analysis of study designs, safety profiles, pharmacodynamics, and tumor responses.
- Identification of potential biomarkers for treatment sensitivity or resistance.
Main Results:
- Window of opportunity settings allow for safety, pharmacodynamic, and initial response assessments in treatment-naïve HNSCC.
- These studies can identify biomarkers predictive of treatment outcomes.
- Several challenges inherent to this trial design have been identified.
Conclusions:
- Early window studies are valuable for evaluating novel therapies in HNSCC.
- Addressing identified challenges is crucial for optimizing future trial designs.
- Further research in this setting can improve therapeutic strategies for HNSCC.
Related Concept Videos
Arteries of the Head and Neck
The internal carotid arteries supply blood to the anterior portion of the cerebrum. They enter the...
Veins of Head and Neck
On the other hand, the vertebral veins, unlike their arterial counterparts, are not primarily responsible for brain drainage. Instead, they drain the cervical vertebrae, spinal cord, and some small...
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Trial and Error and Algorithm
Muscles of the Anterior Neck

