NCT01330056

Functional Organ Preservation Surgery

A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective randomized controlled trial comparing functional organ preservation surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to preserve the organ function without compromising oncologic safety and survival.

Detailed description

This prospective study compare the following items between two groups: * Functional outcomes: laryngeal, pharyngeal, and quality of life * Oncological outcomes: survivals, locoregional controls * Combined imaging and molecular biomarkers with follow-up data The functional organ preservation surgery (FOPS) is defined as a surgery preserving the laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may include: * Radical tonsillectomy or other oropharyngeal resection * Partial laryngectomy or pharyngectomy * Transoral laser microresection * Transoral robotic surgery (TORS) * Reconstructive surgery may be combined with primary resection * Neck dissection may be indicated in some patients * Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients according to their pathologic reports. The standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT) alone may be indicated for some patients under tumor-board discussion. The salvage surgery may be indicated for patients with residual or recurrent diseases after CRT or RT.

Conditions

• Organ Preservation

Interventions

Type	Name	Description
PROCEDURE	FOPS	* Functional organ preservation (FOPS) as a first-line treatment modality * Postoperative RT or CRT may be included for the patients of this group.
RADIATION	CRT	* Concurrent chemoradiotherapy as a first-line treatment modality * Salvage surgery may be applied for the patients with persistent or recurrent cancers after RT or CRT

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2011-04-06
• Last updated: 2019-07-09

Locations

1 site across 1 country: South Korea