Predicting treatment outcomes for head and neck cancer using imaging and tumor biology
Prediction of Outcome After Chemoradiotherapy for Head and Neck Cancer Using Functional Imaging and Tumor Biology. A Prospective, Non-commercial and Mono-centric Study.
This study is trying to see if combining imaging and tumor genetics can help doctors predict the best treatment for patients with advanced head and neck cancer, so they can give the right level of care to each person.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Leuven) |
| Trial ID | NCT01829646 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a prognostic model for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) undergoing chemoradiotherapy. By combining clinical parameters with genetic characteristics of the tumor and advanced imaging techniques like diffusion weighted and dynamic contrast enhanced MRI, the researchers hope to tailor treatment more effectively to individual patients. The goal is to identify which patients may benefit from less intense treatment to reduce toxicity, while also determining who may require more aggressive therapy due to a higher risk of recurrence.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with non-metastatic locally advanced oropharyngeal cancer scheduled for chemoradiotherapy.
Not a fit: Patients with prior irradiation to the head and neck region or those with distant metastases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans that improve outcomes and reduce side effects for patients with head and neck cancer.
How similar studies have performed: Other studies have shown promise in using imaging and genetic profiling to predict treatment outcomes in cancer, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years old * Patients with non-metastatic locally advanced oropharyngeal cancer who will be treated with chemoradiotherapy, as decided after multidisciplinary consultation. * A karnofsky performance status ≥ 70% * Gender: Male - Female * Informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: * Prior irradiation to the head and neck region * Medical contraindications for any of the planned investigations * Distant metastases * Pregnant or lactating women * Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study * Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Where this trial is running
Leuven
- Departement of Radiation Oncology — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Sandra Nuyts, PhD, MD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Daan Nevens, MD
- Email: daan.nevens@uzleuven.be
- Phone: 0032473583893
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.