Clinical trial · Interventional
Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer
Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus 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)
The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.
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 |
|---|---|---|---|
| Paranasal Sinus Neoplasms | Paranasal Sinus Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| targeted radiation therapy | Procedure | — | UNRESOLVED |
| tumor resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Local control of cancer at two years post treatment
- measure
- Response to preoperative chemoradiation
Secondary outcomes (5)
- measure
- Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
- measure
- Identification of factors that are associated with inoperability
- measure
- Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
- measure
- Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Karnofsky Performance Score: \>= 60 * Creatinin clearance \>= 50 ml/min or serum creatinine =\<1.5 mg/dl * Total bilirubin, AST, ALT =\< 1.5 X laboratory uln * ANC \>= 2000/mm3, platelets \>= 100,000/mm3 * Serum calcium within normal range * T3 or T4 state tumors of paranasal sinuses * Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma Exclusion Criteria: * History of other malignancy in the last 3 years * Other serious comorbidity that may significantly reduce the survival in next 5 years * Pregnant or lactating women * History of radiation to the head and neck region * Paranasal sinus tumor is recurrent after prior treatment * Presence of cervical node metastasis * Presence of distant metastasis * Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion
References
Publications (0)
Data not yet available