| CTRI Number |
CTRI/2022/08/044845 [Registered on: 23/08/2022] Trial Registered Prospectively |
| Last Modified On: |
03/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
RESULTS OF TWO MODES (GAMMA KNIFE AND RUTHENIUM PLAQUE BRACHYTHERAPY) FOR TREATMENT OF UVEAL MELANOMA (A TYPE OF EYE CANCER) |
|
Scientific Title of Study
|
CLINICAL OUTCOMES OF GAMMA KNIFE AND RUTHENIUM PLAQUE BRACHYTHERAPY IN THE TREATMENT OF UVEAL MELANOMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavna Chawla |
| Designation |
Professor, Department of Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences,
Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9654842424 |
| Fax |
|
| Email |
bhavna2424@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Chawla |
| Designation |
Professor, Department of Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences,
Ansari Nagar, New Delhi 110029
DELHI
110029
India |
| Phone |
9654842424 |
| Fax |
|
| Email |
bhavna2424@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruja Gangwani |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences,
Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9958449680 |
| Fax |
|
| Email |
arujagangwani97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
All India Institute of Medical Sciences, Ansari Nagar,New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavna Chawla |
All India Institute of Medical Sciences, New Delhi |
Dr Rajendra Prasad Centre For Ophthalmic Sciences, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029
South
DELHI |
9654842424
bhavna2424@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for post graduate research, All India Institute of Medical Sciences,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C693||Malignant neoplasm of choroid, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GAMMA KNIFE |
Patients of uveal melanoma will be subjected to gamma knife.A high resolution MRI will be done to provide orientation and localization of target.Treatment planning is done in relation to spherical points on the gamma knife planning system. |
| Comparator Agent |
RUTHENIUM PLAQUE BRACHYTHERAPY |
Patients of uveal melanoma will be subjected to Ruthenium Plaque Brachytherapy.Ruthenium plaque is sutured at the required position and radiation dose is delivered according to the predefined dose as calculated by the plaque stimulator software. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
A) CHOROIDAL MELANOMA
1. GAMMA KNIFE
1. Small,medium and large choroidal melanoma
according to COMS Classification.
2. Patients giving consent for the study
2. RUTHENIUM PLAQUE BRACHYTHERAPY
1. Small to medium(thickness <7mm ) choroidal
melanoma according to COMS Classification.
2. Patients giving consent for the study
B) IRIS/CILIARY MELANOMA
1. GAMMA KNIFE
1. Involvement of 1-6 clock hours of iris
2. Largest basal dimension of tumor >3 mm
3. Patients giving consent for the study
2) RUTHENIUM PLAQUE BRACHYTHERAPY
1. Involvement of 1-6 clock hours of iris
2. Largest basal dimension of tumor >3 mm
3. Patients giving consent for the study |
|
| ExclusionCriteria |
| Details |
A) CHOROIDAL MELANOMA
1. GAMMA KNIFE
1. Tumors with gross extraocular extension
2. Patients with painful blind eye
3. Presenting with metastatic choroidal
melanoma
2. RUTHENIUM PLAQUE BRACHYTHERAPY
1. Tumors with gross extraocular extension
2. Patients with painful blind eye
3. Presenting with metastatic choroidal
melanoma
B) IRIS/ CILIARY BODY MELANOMA
1. GAMMA KNIFE
1. Seeding in anterior chamber
2. Melanomas with secondary glaucoma
3. Scleral/extraocular extension
4. Tapioca/ Ring Melanoma
2. RUTHENIUM PLAQUE BRACHYTHERAPY
1. Seeding in anterior chamber
2. Melanomas with secondary glaucoma
3. Scleral/extraocular extension
4. Tapioca/ Ring Melanoma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Globe salvage rate-percentage of cases where enucleation was not required
2. Local tumor control-
%decrease in tumor diameter
and height on USG.
3. Vision salvage rate-assessing post procedure visual outcomes
4. Local recurrence of tumor
5. Need for enucleation
6. Occurence of Extraocular
extension
7. Occurence of Distant
metastasis |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Development of local complications subsequent to therapy:
1. Radiation Retinopathy
2. Radiation optic neuropathy
3. Glaucoma
4. Radiation Maculopathy
5. Cataract
6. Corneal Erosions |
1 month, 2 month,3 month,4 month,5 month,6 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Uveal Melanoma is the most common primary malignant intraocular tumor in adults with 80% of them originating in choroid.This study aims at evaluating the clinical outcomes of two globe salvage therapies that is Stereotactic Radiosurgery using Gamma Knife and Ruthenium Plaque Brachytherapy in the treatment of Uveal Melanoma.The study design is a prospective interventional study with 20 patients - with 10 of them being subjected to Gamma Knife and 10 of them being subjected to Ruthenium Plaque Brachytherapy. The patients shall be subjected to one of the two treatment modalities and followed up for a minimum period of 6 months. At each visit, patients will be assessed for all clinical parameters,and investigated through OCT and USG. MRI Orbit will be done at 6 months. Globe Salvage Rate, local tumor control, vision salvage rate , development of local complications, local recurrence of tumor and need for enucleation shall be evaluated. |