Functional Organ Preservation Surgery (FOPS)

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

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 Overview

• Status: Completed
• Conditions: Organ Preservation
• Intervention / Treatment: Procedure: FOPS; Radiation: CRT

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.

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with squamous cell carcinomas arising in the oropharynx, larynx, or hypopharynx
• Resectable tumors without distant metastases
• age range: 18-80 years
• Pretreatment Karnofsky performance scale > or 70%
• Operable patients
• No significant loss of pretreatment larynx and pharyngeal functions

Exclusion Criteria:

• Patients with a present or previous history of other cancers except benign tumors, premalignant lesions, carcinoma-in-situ (at some organ sites), well-differentiated thyroid carcinoma and low-grade salivary gland cancers (from tumor-board decision whether the tumors significantly affect the survival outcomes)
• Other organ-site cancers
• Low-performance status or non-operable patients
• Non-resectable or distant-metastatic tumors
• Extensive primary or neck nodal diseases
• Significant pretreament loss of laryngeal or pharyngeal functions
• cT1N0 glottic carcinomas

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: FOPS; Functional organ preservation surgery (FOPS) group as a first-line treatment modality; Postoperative RT or CRT may be included for the patients of this group	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.
ACTIVE_COMPARATOR: CRT; Concurrent chemoradiotherapy or radiotherapy group as a first-line treatment modality; Salvage surgery may be applied for the patients for persistent or recurrent cancers after CRT or RT	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ preservation rate	The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	The time frame may be extended to 5 years.	2 years
Locoregional control rate	The time frame may be extended to 5 years	2 years

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Jong-Lyel Roh, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (ESTIMATE): April 6, 2011

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Laryngeal and pharyngeal preservation, survivals
• Other Study ID Numbers: 2010-001