At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of the oropharynx
- ✓Plan for gross total surgical resection via trans-oral surgery with unilateral neck dissection or chemoradiotherapy with cisplatin
- ✓Cisplatin eligibility required even if alternate used due to drug shortage
- ✓No distant metastases on diagnostic imaging within 16 weeks prior to registration
- ✕Pregnant or nursing women
- ✕Men or women of childbearing potential unwilling to use adequate contraception
- ✕Severe comorbid systemic illnesses or concurrent disease interfering with safety/toxicity assessment
- ✕Immunocompromised patients or HIV positive
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy
In Brief
A Phase 2 clinical trial evaluating Biospecimen Collection, Cisplatin, and 11 other interventions for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and 6 related conditions. Currently recruiting, targeting 455 participants across 3 sites.
Signals
Detailed Summary
This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving chemotherapy along with radiation may kill more tumor cells. However, the cancer can recur or can spread to other parts of the body and all treatments can be associated with side effects. The purpose of this study is to evaluate a blood-based biomarker, using the NavDx testing device, for head and neck cancers in order to see if it can help improve selection of the intensity of treatment in order to best balance the side effects of treatment with the goal of decreasing cancer recurrence. This test could aid in early detection of recurrence and salvage therapy.
Study Details
Timeline
Interventions
Undergo blood and saliva specimen collection for NavDx testing
Given IV
Undergo CT scan
Undergo DART
Given IV
Undergo IMPT
Undergo IMRT
Undergo MRI
Undergo MBSS
Undergo observation
Undergo PET scan
Ancillary studies
Ancillary studies