Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01330056
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.
Study:
NCT01330056
Study Brief:
Protocol Section:
NCT01330056