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Functional Organ Preservation Surgery

NCT01330056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2019-07-09

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Jong-Lyel Roh, MD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-12-31
Completion
2017-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330056 on ClinicalTrials.gov