| 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
|
|
|
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
|
|
|
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
|
|
|
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. |