Functional Organ Preservation Surgery

NCT01330056 | Completed DMC

• 1 other identifier: 2010-001
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Preservation

Keywords

Laryngeal and pharyngeal preservation, survivals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survival rate

  2 years

• Locoregional control rate

  2 years

Study Arms (2)

FOPS

ACTIVE COMPARATOR

* 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

CRT

ACTIVE COMPARATOR

* 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

Interventions

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.

FOPS

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

CRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jong-Lyel Roh, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: September 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

KR (1)