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Platinum-based Chemotherapy

Induction Therapy for Human Papillomavirus

Phase 2
Waitlist Available
Led By Marshall Posner, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This study is evaluating whether a specific treatment for head and neck cancer may be more effective than other treatments.

Eligible Conditions
  • Human Papillomavirus
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Locoregional control (LRC)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group IV - TPF Induction followed by 60 Gy and Carboplatin AUC 1.5Experimental Treatment4 Interventions
Patient Characteristics: 20-40 Pack-Years, Non-HPV16, Non-OP, T4, N2c, >3 nodes, ENE, or Matted Nodes Induction Therapy: Cisplatin, Docetaxel, Fluorouracil followed by RT 60 GY + Carboplatin AUC 9.0 Docetaxel every 21 days for 3 cycles, Cisplatin every 21 days for 3 cycles, Fluorouracil continuous infusion over 4 days (every 21 days for 3 cycles). Followed by RT 5 days per week for 6 weeks and Carboplatin weekly for 6 weeks.
Group II: Group III - 60 Gy/240 mg/m2Experimental Treatment2 Interventions
Patient Characteristics: 20-40 Pack-Years, Non-HPV16, Non-OP, T1-T2, N1-N2b, T3 N0-N2b RT 5 days per week for 6 weeks and Cisplatin weekly for 6 weeks
Group III: Group II - 54 Gy/200mg/m2Experimental Treatment2 Interventions
Patient Characteristics: <20 Pack-Years, HPV16, OP, T1-T2, N1-N2b, T3 N0-N2b RT 5 days per week for 6 weeks and Cisplatin weekly for 6 weeks
Group IV: Group I - 50 Gy/200 mg/m2Experimental Treatment2 Interventions
Patient Characteristics: <20 Pack-Years, HPV16, OP, T1,T2 N0 RT 5 days per week for 6 weeks and Cisplatin weekly for 5 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,476 Total Patients Enrolled
Marshall Posner, MDPrincipal InvestigatorIchan School of Medicine at Mount Sinai Hospital
6 Previous Clinical Trials
753 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
Effect of Hpv-associated P16<sup>ink4a</sup> Expression on Response to Radiotherapy and Survival in Squamous Cell Carcinoma of the Head and Neck
Lassen, Pernille, Jesper G. Eriksen, Stephen Hamilton-Dutoit, Trine Tramm, Jan Alsner, and Jens Overgaard. 2009. “Effect of Hpv-associated P16ink4a Expression on Response to Radiotherapy and Survival in Squamous Cell Carcinoma of the Head and Neck”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2008.20.2853.
Journal of Clinical OncologyJournal
Human Papillomavirus and Rising Oropharyngeal Cancer Incidence in the United States
Chaturvedi, Anil K., Eric A. Engels, Ruth M. Pfeiffer, Brenda Y. Hernandez, Weihong Xiao, Esther Kim, Bo Jiang, et al.. 2011. “Human Papillomavirus and Rising Oropharyngeal Cancer Incidence in the United States”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2011.36.4596.
JNCI Journal of the National Cancer InstituteJournal
Improved Survival of Patients with Human Papillomavirus-positive Head and Neck Squamous Cell Carcinoma in a Prospective Clinical Trial
Fakhry, C., W. H. Westra, S. Li, A. Cmelak, J. A. Ridge, H. Pinto, A. Forastiere, and M. L. Gillison. 2008. “Improved Survival of Patients with Human Papillomavirus-positive Head and Neck Squamous Cell Carcinoma in a Prospective Clinical Trial”. JNCI Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djn011.
JNCI Journal of the National Cancer InstituteJournal
Improved Survival of Patients with Human Papillomavirus-positive Head and Neck Squamous Cell Carcinoma in a Prospective Clinical Trial
Fakhry, C., W. H. Westra, S. Li, A. Cmelak, J. A. Ridge, H. Pinto, A. Forastiere, and M. L. Gillison. 2008. “Improved Survival of Patients with Human Papillomavirus-positive Head and Neck Squamous Cell Carcinoma in a Prospective Clinical Trial”. JNCI Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djn011.
~0 spots leftby Apr 2025
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