FOPS: Functional Organ Preservation Surgery

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01330056

Collaborator

(none)

264

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Organ Preservation	Procedure: FOPS Radiation: CRT	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Organ preservation rate [2 years]
The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.

Secondary Outcome Measures

Survival rate [2 years]
The time frame may be extended to 5 years.
Locoregional control rate [2 years]
The time frame may be extended to 5 years

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

Asan Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jong-Lyel Roh, MD, PhD, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT01330056

Other Study ID Numbers:

2010-001

First Posted:

Apr 6, 2011

Last Update Posted:

Jul 9, 2019

Last Verified:

Jul 1, 2019

Keywords provided by Jong-Lyel Roh, MD, PhD, Asan Medical Center

Laryngeal and pharyngeal preservation, survivals

Study Results

No Results Posted as of Jul 9, 2019