MedTrace Logo

RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC

NCT04849377 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-07-07

No results posted yet for this study

Summary

The purpose of this research study is to determine the rate of local regional control at 2 years when using de-intensified chemoradiotherapy (CRT) in patients with Human Papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC). Local regional control means no recurrence of the cancer in the head or neck area. Study subjects will be enrolled into 4 groups. Group/treatment will be based on a number of factors, including smoking and drinking history.

Conditions

  • Human Papillomavirus (HPV)
  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

RADIATION

RT 50 Gy

Radiation Therapy (RT) 50 GY

RADIATION

RT 54 GY

Radiation Therapy (RT) 54 GY

RADIATION

RT 60 GY

Radiation Therapy (RT) 60 GY

OTHER

Induction Therapy

Induction Therapy: Cisplatin, Docetaxel, Fluorouracil

DRUG

Carboplatin

Carboplatin AUC 9.0

DRUG

Cisplatin 200

200 mg/m2

DRUG

Cisplatin 240

240mg/m2

Sponsors & Collaborators

Principal Investigators

  • Marshall Posner, MD · Ichan School of Medicine at Mount Sinai Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2022-06-14
Completion
2022-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849377 on ClinicalTrials.gov