Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Nov 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with oropharynx cancer, which is a type of head and neck cancer often associated with the human papillomavirus (HPV). The trial compares a shorter course of radiation therapy that targets the tumor more precisely (called stereotactic boost) with the standard longer treatment, which typically lasts seven weeks. Researchers hope to find out if the shorter treatment is just as effective while possibly causing fewer side effects.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma of the oropharynx that is HPV-positive. You also need to be in good enough health to undergo treatment and follow-up. If you join the trial, you will receive either the new treatment or the standard treatment, and doctors will monitor your health and progress closely. This trial is currently recruiting participants, and it's important to discuss with your doctor if you meet the eligibility criteria and if this study might be right for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Ability to provide written informed consent.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• • Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
• • Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
• • Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.
• • Primary tumor \< 30 cc
• • Planned for curative chemoradiation
• • For females of child-bearing age, a negative pregnancy test
• Exclusion Criteria:
• • Clinical N3 classification, as per AJCC 8th edition
• • Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).
• • Previous irradiation of the head and neck region
• • Previous surgery of the HNC region (except for incisional or excisional biopsies)
• • Pregnancy or breastfeeding
• • Connective tissue disease
• • Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
• • Non-Cisplatin concurrent chemotherapy
• • Prior induction chemotherapy