Health Condition 1: D106- Benign neoplasm of nasopharynx
Conditions
Interventions
Intervention1: Sirolimus: Oral sirolimus 2 mg/day in two divided doses for 3 months
Control Intervention1: not applicable: not applicable
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients aged 10-30 years with radiologically confirmed NA (Stage IIC, IIIA, or IIIB) 2)Fit to receive systemic sirolimus therapy and undergo surgical excision 3)Willing to comply with follow-up and consent procedures
Exclusion criteria
Exclusion criteria: 1)Early-stage NA (Stage IA–IIB) 2)Contraindications to sirolimus (e.g., hypersensitivity, significant hepatic/renal dysfunction) 3)Prior treatment (surgical, radiotherapeutic, or medical) Inability to undergo follow-up MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of oral sirolimus in reducing tumor volume and stage in patients with nasopharyngeal angiofibroma as assessed by contrast-enhanced MRI of the head and neck (CE-MRI )Timepoint: Radiological imaging at the time of enrolment and after 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To document and evaluate any adverse effects or toxicity related to oral sirolimus during the treatment period.Timepoint: Every 2 weeks from the time of enrolment for a duration of 3 months;To assess the impact of sirolimus on intraoperative parameters like s like surgical duration, estimated blood loss, and need for blood transfusionTimepoint: After completion of sirolimus treatment , patient might undergo surgery for excision. this secondary outcome will be measured at the time of surgery. the exact time point of surgery is variable;To assess histological changes in tumor vascularity and stromal characteristics posttreatment.Timepoint: The exact time point of this secondary outcome is variable | — |
Countries
India
Contacts
Public ContactKondapalli Laasya
AIIMS DELHI
Outcome results
None listed