Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 1:02 AM
Study NCT ID:
NCT01330056
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2011-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Organ Preservation Surgery
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOPS
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: