Functional Organ Preservation Surgery - Full Text View

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 Rate	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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT01330056 History of Changes
Other Study ID Numbers:	2010-001
Study First Received:	April 4, 2011
Last Updated:	June 22, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:

Laryngeal and pharyngeal preservation, survivals

Additional relevant MeSH terms:

Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on May 19, 2013

Functional Organ Preservation Surgery (FOPS)