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A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma

18 Years
80 Years
Open (Enrolling)
Organ Preservation Rate

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Trial Information

A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma

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

- 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.

Inclusion Criteria:

- Patients with squamous cell carcinomas arising in the oropharynx, larynx, or

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Organ preservation rate

Outcome Description:

The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jong-Lyel Roh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

September 2010

Completion Date:

December 2017

Related Keywords:

  • Organ Preservation Rate
  • Laryngeal and pharyngeal preservation, survivals
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms