Clinical trial NCT01330056: Functional Organ Preservation Surgery
Official title: A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Preservation
Keywords: Laryngeal and pharyngeal preservation, survivals
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Organ preservation rate
timeFrame: 2 years
Secondary outcomes:
measure: Survival rate
timeFrame: 2 years
measure: Locoregional control rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jong-Lyel Roh, MD
role: PRINCIPAL_INVESTIGATOR
References: