Functional Organ Preservation Surgery

Organ Preservation Clinical Trial

— FOPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330056
• Other study ID #: 2010-001
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Organ Preservation
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival rate	The time frame may be extended to 5 years.	2 years
Secondary	Locoregional control rate	The time frame may be extended to 5 years	2 years