Radiotherapy for elderly patients with head and neck cancer
Non Elective Vulnerable Elderly Radiotherapy
This study is testing a special type of radiotherapy for older patients with advanced head and neck cancer who can't have surgery or other treatments, to see if it can help control the cancer effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero Universitaria Policlinico Modena Academic / other |
| Drugs / interventions | cetuximab, chemotherapy |
| Locations | 1 site (Modena) |
| Trial ID | NCT04832555 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of non-elective radiotherapy in elderly patients with locally advanced squamous cell carcinoma of the head and neck who are not suitable for curative treatments like radio-chemotherapy or surgery. The aim is to determine if this tailored radiotherapy approach can achieve comparable loco-regional control to historical cohorts. The study focuses on a specific group of frail elderly patients, addressing a significant gap in treatment options for this demographic. Data will be collected to ensure a homogeneous patient population for analysis.
Who should consider this trial
Good fit: Ideal candidates are patients over 70 years old with locally advanced, non-metastatic head and neck squamous cell carcinoma who are not eligible for standard treatments.
Not a fit: Patients under 70 years old or those with metastatic disease or other specific exclusions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a viable treatment option for elderly patients with head and neck cancer who currently have limited options.
How similar studies have performed: While there is ongoing research in this area, this specific approach for frail elderly patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * locally advanced non-metastatic HNSCC patients older than 70 years * Primary tumor clinically and radiologically detectable and measurable (staging according to ed. TNM VII and also VIII. * patients defined by the tumor board (ENT, Oncologist, Radiotherapist, Nutritionist) as 1) not eligibles for RTCT / RT-cetuximab treatment 2) not amenable to radical surgery and 3) not candidates for treatments with palliative intent/best supportive care * Availability of staging with CT/PET for distant metastasis and CT/MRI for primary tumor * Karnofsky performance status (KPS) ≥60/100 * Oropharynx , Hypopharynx and Larynx, Oral cavity: stage III and IV and Unknown primitive P16-POSITIVE Exclusion Criteria: * Age less than 70 years * Staging exams done 45 days before the date of the beginning of the treatment * Subsites: nasopharynx, salivary glands, paranasal sinuses. Metastatic disease * Gross total excision * All subsites concerned if N3. * Squamous cell neoplasms of the glottic larynx T1-T2 N0. * Unknown primary HPV negative or EBV positive. * Presence of distant metastases or sub-clavicular lymphadenopathies. * Previous surgery on T and/or N except diagnostic tonsillectomy. * 3D-conformational radiotherapy technique
Where this trial is running
Modena
- AOUPoliclinicoModena — Modena, Italy (Recruiting)
Study contacts
- Study coordinator: Pasquale Mighali, MD
- Email: pasqualemighali@aou.mo.it
- Phone: +39 0594225868
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.