FMISO-based Adaptive Radiotherapy for Head and Neck Cancer

Launched by UNIVERSITY HOSPITAL OLOMOUC · Apr 20, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to treat head and neck cancer by using advanced imaging to identify areas of the tumor that are not getting enough oxygen, a condition known as hypoxia. It is estimated that about 80% of head and neck tumors have this issue, which makes them harder to treat with radiation. By using a special imaging technique called FMISO PET/CT, doctors can find these difficult areas and potentially deliver higher doses of radiation to them, a method known as "dose painting." The goal is to improve treatment outcomes for patients with certain types of head and neck cancers.

To participate in this trial, participants should have a confirmed diagnosis of specific types of head and neck squamous cell carcinoma, such as oropharyngeal or laryngeal cancer, and be in the later stages of the disease (stage III or IV). They should also be able to undergo a combination of chemotherapy and radiation treatment. The study is open to all genders and is currently recruiting individuals aged 65 to 74 who meet these criteria. If eligible, participants can expect to receive personalized treatment based on their tumor’s unique characteristics, along with regular monitoring throughout the study. It’s important to note that individuals with certain health conditions or prior treatments may not be eligible to join the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area
• • Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1
• • Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • Adequate kidney and liver function
• Exclusion Criteria:
• • Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary)
• • Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer
• • Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or unknown primary head and neck cancer
• • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
• • Known active Hepatitis B or C
• • History of Human Immunodeficiency Virus (HIV)
• • History of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
• • Previous allogeneic tissue/solid organ transplant
• • Active infection requiring systemic therapy