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NCT Number: NCT01330056

Functional Organ Preservation Surgery

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.

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Key information

Conditions

Organ Preservation Laryngeal Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOPS

Procedure
  • Functional organ preservation (FOPS) as a first-line treatment modality
  • Postoperative RT or CRT may be included for the patients of this group.

CRT

Radiation
  • 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

Primary outcomes

  1. Organ preservation rate

    Time frame: 2 years

    The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.

Secondary outcomes

  1. Survival rate

    Time frame: 2 years

    The time frame may be extended to 5 years.

  2. Locoregional control rate

    Time frame: 2 years

    The time frame may be extended to 5 years

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: FOPS

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Apr 6, 2011
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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