A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positiv… (NCT05491512) | Clinical Trial Compass
RecruitingPhase 2
A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer
United States121 participantsStarted 2022-08-04
Plain-language summary
The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI
✓. Patient must have excisional biopsy or core biopsy done in order to be on protocol
✓. Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable
✓. Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male)
✓. Bilirubin \< 2 mg/dl
Exclusion criteria
✕. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
✕. Transmural myocardial infarction within the last 6 months
✕. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
✕. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
What they're measuring
1
Number of participants with any locoregional recurrences