NCT03388931

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The novel radiotherapy schedule that is the subject of this study is only slightly different from the program that has been used in the cooperative group trial RTOG 9003. The radiation therapy dose schedule in our study twice-daily alternating fractions over 30 treatment days. The Biologically Effective Dose (BED) of this schedule is about 11% higher than our standard schedule twice-a-day. During radiotherapy, patients will receive chemotherapy with our standard program of weekly.

Conditions

• Advanced Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Increased radiation therapy dose
COMBINATION_PRODUCT	Chemotherapy	Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician

Timeline

• Start date: 2019-02-04
• Primary completion: 2019-05-06
• Completion: 2019-05-06
• First posted: 2018-01-03
• Last updated: 2019-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study