NCT07044635RecruitingPhase 2
Radiation Therapy in Reduced Dose and Hypofractionated Schedule After Trans-Oral Robotic Surgery in Intermediate Risk HPV-Mediated Oropharyngeal Squamous Cell Carcinoma
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Stable or improved FACT-HN at 6 months post-treatment compared to baseline.
Study Overview
Brief Summary
The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Step 1 Registration: Pre-Operative Eligibility
- •Inclusion Criteria:
- •Participant aged ≥ 18 years.
- •Diagnosis of oropharyngeal squamous cell carcinoma.
- •Eligible to receive transoral robotic surgery.
- •P16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor.
- •Pre-operative TTMV-HPV DNA test collected.
- •Standard of care tests completed within 60 days of registration may be used for screening.
- •Tests results are not required to confirm eligibility for step 1 registration.
- •ECOG Performance Status ≤ 2
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria
- •History of prior mucosal head and neck cancer treated with radiation therapy
- •Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study
- •Participant has smoked cigarettes within 1 month of registration
- •Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
- •Known distant metastatic disease.
- •Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [participants may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- •Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- •Step 2 Registration - Experimental Arm
- •Inclusion Criteria:
- •Completion of trans-oral robotic surgery.
- •Pre- and post-operative TTMV-HPV DNA test results obtained.
- •For participants of child bearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •< 50 years of age:
- •Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- •Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- •≥ 50 years of age:
- •Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- •Had radiation-induced menopause with last menses >1 year ago; or
- •Had chemotherapy-induced menopause with last menses >1 year
- •Participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.5.
- •Exclusion Criteria:
- •Meets ALL of the following criteria for low-risk disease (Note: participants may meet some without being excluded):
- •Pre-operative TTMV-HPV DNA positive
- •Post-operative TTMV-HPV DNA negative
- •Disease: pT1 with ≤ 1 lymph nodes OR pT2N0
- •<10 pack year smoking
- •No extranodal extension
- •Negative surgical margins
- •No perineural invasion
- •No lymphovascular invasion
- •Meets ANY of the following criteria for high-risk:
- •Post-operative TTMV-HPV DNA positive
- •Surgical margin positive -->1 mm extranodal extension --≥ 5 lymph nodes
- •Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [participants may not receive the drug through a feeding tube], social/ psychological issues, etc.)
Arms & Interventions
10 fractions of radiation therapy
Experimental
Intervention: Radiation Therapy (Radiation)
Radiation therapy with chemotherapy, if applicable, per standard of care
Active Comparator
Intervention: Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Stable or improved FACT-HN at 6 months post-treatment compared to baseline.
Time Frame: 2 years
To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.
Stable or improved FACT-HN at 6 months post-treatment compared to baseline.
Time Frame: 2 years
To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.
Secondary Outcomes
- Stable or improved FACT-HN at 12 months post-treatment compared to baseline.(4 years)
- Stable or improved MDADI defined by patient quality of life.(4 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.(2 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).(2 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.(2 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.(2 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study drug.(2 years)
- Progression-free survival (PFS) as defined as the time from surgery to the time of recurrence or death from any cause.(4 years)
- The proportion of participants who experience local-regional recurrence.(4 years)
- The proportion of participants who experience recurrence.(4 years)
- This endpoint is restricted to participants who are able to work prior to treatment. Of those participants, the proportion who remain able to work 6 months after treatment as assessed by the FACT-HN.(4 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.(2 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.(2 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.(2 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study drug.(2 years)
- Progression-free survival (PFS) as defined as the time from surgery to the time of recurrence or death from any cause.(4 years)
- The proportion of participants who experience local-regional recurrence.(4 years)
- The proportion of participants who experience distant recurrence.(4 years)
- The proportion of participants who experience recurrence.(4 years)
- Overall survival (OS) as defined as the time from registration until death from any cause.(4 years)
- This endpoint is restricted to participants who are able to work prior to treatment. Of those participants, the proportion who remain able to work 6 months after treatment as assessed by the FACT-HN.(4 years)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).(2 years)
- Stable or improved MDADI defined by patient quality of life.(4 years)
- Stable or improved FACT-HN at 12 months post-treatment compared to baseline.(4 years)
Investigators
Study Sites (1)
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