HPV Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
Conditions
Brief summary
This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.
Detailed description
The purpose of this research is to determine if a decrease in the dose of radiation to regions which have no visible cancer will be as effective as the standard dose. The dose to all visible cancer remains unchanged to the standard radiation approach. The researchers believe that a lower dose could be just as helpful for treatment, while reducing the side effects of radiation and improving quality of life. The current standard care treatment for OPSCC can have debilitating side effects. Using a decreased dose of 30 Gy from 46-54 Gy to regions without visible cancer but which have a risk of microscopic cancer might be just as effective for treating cancer with less side effects. The combination of these approaches is not considered the current standard of care. Patients will continue to receive standard systemic therapy of cisplatin during radiation therapy.
Interventions
DRUGCisplatin
Subjects will continue to receive standard systemic therapy of cisplatin during radiation therapy. Weekly SOC Cisplatin at a dose of 40mg/m2 or every 3-week dosing of 100mg/m2 will be administered per institutional guidelines during radiation therapy. The first cisplatin infusion should be initiated during the window from 24 hours before, to 48 hours after the first scheduled radiation treatment. Skipped cisplatin infusions should not be made up, and the last cisplatin infusion should be no later than 7 days after the last fraction of radiation.
RADIATIONRadiotherapy
Radiotherapy will involve a sequential boost approach. Treatment will begin with coverage of the primary site and elective nodal regions to 30 Gy, after which treatment volumes will be reduced to primary site and involved nodes only with PTV margin to 70 Gy.
Sponsors
Sara Medek
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation. 2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining. 3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8. 4. Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation. 5. Age ≥18 years. 6. ECOG performance status ≤2. 7. Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist. 8. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 9. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* 1\. Patients with metastatic or recurrent disease. 2\. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive). 3\. Prior radiotherapy resulting in overlap of radiation therapy fields. 4\. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study. 5\. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator. 6\. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the Investigator. 7\. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or not preferable, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS) | 2 years post treatment | To evaluate the efficacy of a reduction in dose and volume to all clinical target volumes (CTV) in patients with HPV-positive squamous cell carcinoma of the oropharynx (OPSCC) using 2-year Progression-Free Survival (PFS). Efficacy will be determined by the PFS rate at 2 years post-treatment, through continuous assessment with a boundary of 10% progression at 2 years (90% 2 year PFS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluated per CTCAE v6 | Adverse events collected through 30 days post treatment and SAEs through 90 days post-treatment or until commencement of new anti-cancer therapy, whichever occurs first. | To evaluate safety by collecting adverse events per CTCAE v6 in patients who have HPV positive SCC of the oropharynx using a reduction in primary tumor and nodal CTV dose to 30 Gy. |
| Quality of life measured by MDADI | Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT | The MDADI is a patient-reported outcome (PRO) instrument designed to assess swallowing-related quality of life in patients with head and neck cancer and dysphagia. It evaluates the functional, emotional, and physical impact of swallowing difficulties on daily life. The scale ranges from 20 - 100. Higher scores indicate better swallowing function and better swallowing-related quality of life. Lower scores indicate worse dysphagia-related quality of life To assess the impacts on quality of life on patients who have HPV positive SCC of the oropharynx who receive a reduction in CTV dose to 30 Gy as well as a reduction in CTV volumes, via the EORTC QLQ-C30 at baseline, week 7/EOT, 6 months, 12 months 18 months and 24 months following completion of radiation therapy. |
| Quality of life measured by EORTC QLQ-C30 | Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT | European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30. t is a validated patient-reported outcome (PRO) instrument designed to assess health-related quality of life (HRQoL) in patients with cancer across clinical trials and routine practice. The transformed scale ranges from 0 - 100. Functional and Global Health scales: higher = better Symptom scales/items: higher = worse To assess the impacts on quality of life on patients who have HPV positive SCC of the oropharynx who receive a reduction in CTV dose to 30 Gy as well as a reduction in CTV volumes, via the EORTC QLQ-C30 at baseline, week 7/EOT, 6 months, 12 months 18 months and 24 months following completion of radiation therapy. |
Countries
United States
Contacts
CONTACTUCCC Clinical Trials Office
CONTACTSara Medek, MD
Outcome results
None listed