Functional Organ Preservation Surgery

NCT ID: NCT01330056

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Organ Preservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

FOPS

Intervention Type: 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

• 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

Group Type: ACTIVE_COMPARATOR

CRT

Intervention Type: 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

Interventions

FOPS

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

Intervention Type: PROCEDURE

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

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jong-Lyel Roh

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong-Lyel Roh, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2010-001

Identifier Type: -

Identifier Source: org_study_id