A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Trea… (NCT03274414) | Clinical Trial Compass
CompletedPhase 2
A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages
United States3 participantsStarted 2017-09-01
Plain-language summary
This study is being done to test a new treatment plan for large tumors in the sinus or nasal cavity that will include endoscopic surgery plus chemotherapy and proton-beam radiation therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age greater than or equal to 18 years.
* Histopathologically confirmed diagnosis of one the following cancer types:
* Squamous cell carcinoma
* Esthesioneuroblastoma
* Adenoid cystic carcinoma
* Adenocarcinoma
* Paranasal sinus/nasal cavity malignancy is considered unresectable with negative margins surgery or resection would be considered excessively morbid. This could include lesions with:
* Carotid involvement
* Cavernous sinus invasion
* Brain invasion
* Orbital apex
* Intraconal space
* Pterygoid musculature involvement
* Invasion of the clivus
* Resection of at least 80% of the volume of the tumor is feasible. Resectability will be determined by the surgeon and radiologist after discussion among the multidisciplinary team. For patients who have had surgery at an outside institution, the same parameters will be thoroughly screened to ensure the patient met the same inclusion criteria and resection standards.
* Patients must be a candidate for surgery (as per treating surgeon) and be able to tolerate proton radiation and chemotherapy (as per treating radiation oncologist and medical oncologist).
* Karnofsky performance statue \>/= 70
* The subject has organ and marrow function and laboratory values rendering safe administration of Cisplatin:
* The ANC \>/= 1000/mm3 without colony stimulating factor support
* Platelets \>/= 100,000/mm3
* Hemoglobin \>/= 9 g/dL
* Bilirubin \</= 1.5 mg/dL the ULM. For subjects with Gilb…
What they're measuring
1
Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors