Improving treatment for advanced head and neck cancer with Cetuximab and radiotherapy
Accelerated Modulated Fractionation (SIB-IMRT) for the Treatment of Locally Advanced Squamous Cell Carcinoma From Head and Neck District
PHASE2 · European Institute of Oncology · NCT03001570
This study is testing if adjusting radiation treatment while using the drug Cetuximab can help people with advanced head and neck cancer who can't have standard chemotherapy feel better and have better results.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | European Institute of Oncology (other) |
| Drugs / interventions | chemotherapy, Cetuximab, radiation |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT03001570 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the toxicity and benefit ratio for patients with locally advanced head and neck squamous carcinoma receiving concurrent radiotherapy and the anti-EGFR monoclonal antibody Cetuximab. It focuses on modulating the radiation therapy dose per fraction based on the pharmacokinetics of Cetuximab. The study includes patients who are not eligible for standard chemoradiotherapy and evaluates the effects of different radiation schedules on treatment outcomes. The goal is to provide a more effective and tolerable treatment option for this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with locally advanced squamous carcinoma of the oropharynx, larynx, or hypopharynx who overexpress EGFR and are not eligible for curative chemoradiotherapy.
Not a fit: Patients with distant metastases, oral cavity or rhinopharynx neoplasms, or severe systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with advanced head and neck cancer.
How similar studies have performed: While there have been indirect comparisons with standard treatments, this specific approach of modulating radiation therapy in conjunction with Cetuximab is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histological proof of locally advanced squamous carcinoma of oropharynx, larynx, hypopharynx (stage III and Iva) * Overexpression of EGFR (\>50%) * Patients previously considered non-eligible for curative radio-chemotherapy for clinical reasons. * Performance Status (ECOG) ≤ 2 * Age ≥ 18 years * Possibility of correct administration of treatment * Written informed consent Exclusion Criteria: * Distant metastases * Oral cavity or rhinopharynx neoplasm * Need of cutaneous bolus * Previous treatments on head and neck district * Collagenopathies or other severe systemic disease * Severe cardiopathies or myocardial infarction in the previous 12 months, serious hepatopathies or other diseases with heavy impact on general conditions. * Psychiatric disorders or other conditions preventing from expressing informed consent.
Where this trial is running
Milan, MI
- Division of Radiotherapy European Institute of Oncology — Milan, MI, Italy (RECRUITING)
Study contacts
- Study coordinator: Roberto Orecchia, Prof.
- Email: roberto.orecchia@ieo.it
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carcinoma of the Head and Neck