Overview

This trial is active, not recruiting.

Condition organ preservation
Treatments fops, crt
Sponsor Asan Medical Center
Start date September 2010
End date December 2015
Trial size 264 participants
Trial identifier NCT01330056, 2010-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
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)
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
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

Primary Outcomes

Measure
Organ preservation rate
time frame: 2 years

Secondary Outcomes

Measure
Survival rate
time frame: 2 years
Locoregional control rate
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
Principal investigator Jong-Lyel Roh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Asan Medical Center.