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CTRI Number  CTRI/2025/10/096487 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to see if oral sirolimus can help shrink and reduce the stage of a rare nose tumor in young people 
Scientific Title of Study   A Quasi-Experimental clinical study to evaluate the role of sirolimus in volume and stage reduction in nasopharyngeal angiofibroma : A prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kondapalli Laasya 
Designation  Junior Resident 
Affiliation  AIIMS DELHI 
Address  Department of Otorhinolaryngology , All India Institue of medical sciences, Ansari Nagar , New Delhi

South
DELHI
110029
India 
Phone  6281839752  
Fax    
Email  kondapallilaasya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev Kumar 
Designation  Professor 
Affiliation  AIIMS DELHI 
Address  DEPARMENT OF OTORHINOLARYNGOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR, NEW DELHI

South
DELHI
110029
India 
Phone  9968569892  
Fax    
Email  rajeev9843@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Kondapalli Laasya 
Designation  JUNIOR RESIDENT 
Affiliation  AIIMS DELHI 
Address  Department of Otorhinolaryngology , All India Institue of medical sciences, Ansari Nagar , New Delhi

South
DELHI
110029
India 
Phone  6281839752  
Fax    
Email  kondapallilaasya@gmail.com  
 
Source of Monetary or Material Support  
AIIMS DELHI  
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  All India Institue of medical sciences, Ansari Nagar , New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kondapalli Laasya  Aiims Delhi  Department of Otorhinolaryngology , All India Institue of medical sciences, Ansari Nagar , New Delhi, 110029
South
DELHI 
6281839752

kondapallilaasya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D106||Benign neoplasm of nasopharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Sirolimus  Oral sirolimus 2 mg/day in two divided doses for 3 months 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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 )  Radiological imaging at the time of enrolment and after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To document and evaluate any adverse effects or toxicity related to oral sirolimus during the treatment period.  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
transfusion  
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. 
The exact time point of this secondary outcome is variable 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study is a prospective, quasi-experimental, single-arm interventional trial conducted over two years at AIIMS New Delhi to evaluate the role of oral sirolimus in reducing the volume and stage of nasopharyngeal angiofibroma in adolescent and young adult males. Fifteen patients aged 10 to 30 years with advanced-stage tumors (Radkowski stage IIC, IIIA, or IIIB) were enrolled. After initial clinical examination and baseline investigations, contrast-enhanced MRI scans were performed to assess tumor size and stage. Patients received oral sirolimus at a dose of two milligrams per day for three months, with weekly monitoring of blood parameters and sirolimus levels. After the treatment period, a follow-up MRI was conducted to evaluate changes in tumor volume and staging. Surgery was then performed, and operative details such as duration, blood loss, and complications were recorded. Postoperative tumor specimens were examined histologically for vascularity using CD34 staining, vessel morphology, and stromal features. The findings were compared with untreated historical control samples. The primary objective was to assess tumor volume and stage reduction, while secondary objectives included evaluation of intraoperative outcomes, adverse effects of sirolimus, and histopathological changes following treatment.

 
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