Clinical trial · Interventional
Functional Organ Preservation Surgery
A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Organ Preservation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRT | Radiation | — | UNRESOLVED |
| FOPS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOPS
- description
- * Functional organ preservation surgery (FOPS) group as a first-line treatment modality * Postoperative RT or CRT may be included for the patients of this group
- interventionNames
- Procedure: FOPS
- type
- ACTIVE_COMPARATOR
- label
- CRT
- description
- * Concurrent chemoradiotherapy or radiotherapy group as a first-line treatment modality * Salvage surgery may be applied for the patients for persistent or recurrent cancers after CRT or RT
- interventionNames
- Radiation: CRT
Primary outcomes (1)
- measure
- Organ preservation rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available