Optimizing radiation treatment for p16-positive oropharyngeal cancer
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
This study is testing a lower dose of radiation combined with chemotherapy to see if it helps people with p16-positive oropharyngeal cancer while being safer than standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | chemotherapy, radiation, cetuximab |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT04104945 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on de-intensifying radiotherapy for patients with p16-positive squamous cell carcinoma of the oropharynx. Participants will receive a reduced radiation dose of 60 Gy to the primary tumor and involved lymph nodes, and 54 Gy to at-risk subclinical regions, while omitting certain lymph node regions from treatment. Chemotherapy will be administered concurrently, using either high-dose cisplatin or cetuximab based on the oncologist's discretion. The study aims to evaluate the safety and effectiveness of this approach in a multi-center, single-arm prospective cohort design.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with histologically confirmed p16-positive squamous cell carcinoma of the oropharynx eligible for curative treatment.
Not a fit: Patients with clinical, radiologic, or pathologic involvement of level Ib lymph nodes or those with extensive primary cancer involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to less aggressive treatment options for patients, potentially reducing side effects while maintaining treatment efficacy.
How similar studies have performed: Other studies have explored de-intensified treatment approaches for oropharyngeal cancer, showing promising results, but this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Provide informed consent * ECOG performance status 0-2 * Histologically confirmed squamous cell carcinoma * p16-positive tumor, as determined by immunohistochemistry at local hospital * Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx) * Eligible for curative intent treatment. * Smokers and non-smokers are included * Tumor stage (AJCC 8th edition): T1 to T3 * Nodal stage (AJCC 8th edition): N1 to N2 * Adequate bone marrow function, hepatic, and renal function for chemotherapy (Hemoglobin \> 80 g/L; Absolute neutrophil count \>1.5x109 /L, platelets \> 100 x109/L; Bilirubin \< 35 umol/L; AST or ALT \< 3 x the upper limit of normal; serum creatinine \< 130 umol/L or creatinine clearance ≥ 50 ml/min) Exclusion Criteria: * \- Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland) * Primary cancer with extension and involvement of the oral cavity * Metastatic disease * Contraindications to radiotherapy or chemotherapy * Prior history of head and neck cancer within 5 years * Prior head and neck radiation at any time * Inability to attend full course of radiotherapy or follow-up visits * Pregnant or lactating women
Where this trial is running
Calgary, Alberta
- Tom Baker Cancer Centre — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Harvey Quon, MD — Tom Baker Cancer Centre
- Study coordinator: Harvey Quon, MD
- Email: harvey.quon@ahs.ca
- Phone: 403-521-3619
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.