Organ Preservation
Conditions
Keywords
Laryngeal and pharyngeal preservation, survivals
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.
Interventions
PROCEDUREFOPS
* Functional organ preservation (FOPS) as a first-line treatment modality * Postoperative RT or CRT may be included for the patients of this group.
RADIATIONCRT
* 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
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Organ preservation rate | 2 years | The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 2 years | The time frame may be extended to 5 years. |
| Locoregional control rate | 2 years | The time frame may be extended to 5 years |
Countries
South Korea
Outcome results
None listed