NCT03067610

Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer

A Prospective Phase II Study of Involved Field Elective Volume De-Intensification for Oropharyngeal and Laryngeal Squamous Cell Carcinoma Treated With Intensity Modulated Radiation Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Detailed description

This study aims to significantly improve the acute and late morbidity of patients with oropharyngeal and laryngeal squamous cell carcinoma both by tailoring the elective irradiation only to regions with a legitimate risk of recurrence (\> 5%) and by lowering the elective dose to 40 Gy. Level IB will not be electively treated unless it is involved with pathologic or suspicious lymphadenopathy. Level V will not be treated unless two or more ipsilateral nodal levels are involved (or level V itself has pathologic or suspicious adenopathy). Levels III and IV will only be irradiated if the immediately proximal level contains pathologic lymphadenopathy (i.e. level III irradiated if level II is positive; level IV irradiated if level III is positive). We anticipate that this approach should dramatically improve the acute and late complication profile.

Conditions

• Head and Neck Cancer
• Carcinoma, Squamous Cell
• Neoplasms, Oral
• Neoplasms, Pharyngeal

Interventions

Type	Name	Description
RADIATION	Intensity Modulated Radiation Therapy	The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
DRUG	chemotherapy	chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion

Timeline

• Start date: 2017-01-20
• Primary completion: 2020-12-21
• Completion: 2021-03-09
• First posted: 2017-03-01
• Last updated: 2022-03-17
• Results posted: 2022-03-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study