Functional Organ Preservation Surgery (FOPS)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma|
- Organ preservation rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.
- Survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]The time frame may be extended to 5 years.
- Locoregional control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]The time frame may be extended to 5 years
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: FOPS
Active Comparator: CRT
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330056
|Contact: Jong-Lyel Roh, MD||82-2-3010-3965 ext firstname.lastname@example.org|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Jong-Lyel Roh, MD 82-2-3010-3965 ext 3710 email@example.com|
|Principal Investigator:||Jong-Lyel Roh, MD||Asan Medical Center|