Functional Organ Preservation Surgery (FOPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Jong-Lyel Roh, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01330056
First received: April 4, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention
Organ Preservation
Procedure: FOPS
Radiation: CRT

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330056

Contacts
Contact: Jong-Lyel Roh, MD 82-2-3010-3965 ext 3710 rohjl@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jong-Lyel Roh, MD    82-2-3010-3965 ext 3710    rohjl@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Jong-Lyel Roh, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Jong-Lyel Roh, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01330056     History of Changes
Other Study ID Numbers: 2010-001
Study First Received: April 4, 2011
Last Updated: January 28, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
Laryngeal and pharyngeal preservation, survivals

ClinicalTrials.gov processed this record on September 22, 2014