A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
18 Years
80 Years
Both
Organ Preservation Rate
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
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.
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
Type of Study:
Interventional
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:
No
Principal Investigator
Jong-Lyel Roh, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
2010-001
NCT ID:
NCT01330056
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
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