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Radiotherapy Dose Escalation in Locally Advanced Squamous Cell Carcinoma of the Larynx or Hypopharynx

NCT03388931 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-05-13

No results posted yet for this study

Summary

This is a phase 2 single arm study of a novel schedule of hyperfractionated radiotherapy (RT) in combination with our standard chemotherapy program for patients with stage 3-4 squamous cell carcinoma of the larynx. The primary hypothesis of our study is that the study program will improve Laryngectomy-Free Survival compared to historical controls. The study is limited to patients who would be receiving primary RT-C as standard therapy off-study.

Conditions

  • Advanced Squamous Cell Carcinoma

Interventions

RADIATION

Radiation Therapy

Increased radiation therapy dose

COMBINATION_PRODUCT

Chemotherapy

Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Robert J Amdur, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2019-05-06
Completion
2019-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03388931 on ClinicalTrials.gov