Human Papillomavirus Infection Clinical Trial
Official title:
Phase II Evaluation of Adjuvant Hyperfractionated Radiation and Docetaxel for HPV Associated Oropharynx Cancer
This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy with docetaxel my kill more tumor cells.
PRIMARY OBJECTIVES: I. To assess the cumulative incidence of local/regional failure at 2 years after study registration. SECONDARY OBJECTIVES: I. To characterize the rate of acute grade 3 or higher functional mucosal adverse events (up to 1 month post-radiation therapy [XRT]) associated with adjuvant docetaxel + hyperfractionated radiotherapy (key secondary endpoint). II. To assess changes in overall survival, disease-free survival, distant failure rates, and quality of life (QOL) associated with adjuvant docetaxel and hyperfractionated radiation. III. To characterize other acute adverse events (up to 1 month post-XRT) and late grade 3 or higher non-hematologic adverse events (up to 2 years post-XRT) associated with adjuvant docetaxel + hyperfractionated radiotherapy. TERTIARY OBJECTIVES: I. To determine the genetic alterations of oropharynx tumor specimens and the detection rate of corresponding cell-free deoxyribonucleic acid (cfDNA) in the pre-surgical, post-surgical, and post-radiation blood of oropharynx cancer patients. OUTLINE: Patients receive docetaxel intravenously (IV) over 1 hour on days 1 and 8 and undergo hyperfractionated intensity-modulated radiation therapy (IMRT) twice daily (BID) 5 days a week on days 1-12 for a total of 20 fractions. After completion of study treatment, patients are followed up at 14 days, 1 month, every 3 months for 2 years, every 6 months for 1 year and then annually for 2 years. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05458869 -
Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma
|
||
Completed |
NCT03265743 -
HPV Vaccination in Women With Cystic Fibrosis
|
N/A | |
Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A | |
Completed |
NCT06199128 -
Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients
|
||
Active, not recruiting |
NCT01824537 -
Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study
|
Phase 4 | |
Completed |
NCT01265212 -
Prevalence of Human Papillomavirus in Men Living in the Northern Plains
|
N/A | |
Terminated |
NCT01082861 -
Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination
|
Phase 4 | |
Unknown status |
NCT01087164 -
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers
|
N/A | |
Completed |
NCT00572832 -
Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
|
N/A | |
Completed |
NCT03158220 -
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
|
Phase 3 | |
Recruiting |
NCT05210348 -
Clinical Evaluation of Detection of High Risk HPV in Urine
|
||
Completed |
NCT05680454 -
A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine
|
Phase 1 | |
Completed |
NCT04133610 -
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
|
N/A | |
Completed |
NCT00988884 -
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
|
Phase 3 | |
Not yet recruiting |
NCT05981807 -
HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
|
||
Recruiting |
NCT03302858 -
A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand
|
Phase 2 | |
Completed |
NCT01694875 -
Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
|
N/A | |
Completed |
NCT01205412 -
An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain
|
N/A | |
Completed |
NCT01158209 -
An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt
|
N/A |