Clinical trial · Interventional
Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stopped early for funding and efficacy reasons.
Summary
Brief summary (as posted)
This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 50-60 Gy and 70 Gy | Radiation | — | UNRESOLVED |
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- interventionNames
- Drug: Cetuximab
- Radiation: 50-60 Gy and 70 Gy
Primary outcomes (5)
- measure
- Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
- timeFrame
- At baseline (pre-loading dose) and day 7 post-loading dose
- description
- The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
- measure
- Mean Change in Tumor Phosphorylated EGFR (pEGFR)
- timeFrame
- At baseline (pre-loading dose) and day 7 post-loading dose
- description
- The ratio (fold change) of tumor pEGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin. * Patients will be limited to: * ≥ 70 years of age, OR * with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR * KPS ≤ 80, OR * Creatinine clearance \< 30 cc/min * Laboratory criteria: * WBC \> 3500/ul * Granulocyte \> 1500/ul * Platelet count \> 100,000/ul * Total Bilirubin \< 1.5 X ULN * AST and ALT \< 2.5 X ULN * Patients must give documented informed consent to participate in this study. Exclusion Criteria: * Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer). * Prior head and neck radiation or chemotherapy. * Documented evidence of distant metastases. * Patients with nasopharyngeal carcinoma. * Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment. * Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible. * Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule). * Patients residing in prison.
References
Publications (0)
Data not yet available