| CTRI Number |
CTRI/2017/03/008172 [Registered on: 21/03/2017] Trial Registered Prospectively |
| Last Modified On: |
21/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Single procedure brachytherapy in cervical cancer |
|
Scientific Title of Study
|
A feasibility and safety study of single application multi-fractionated high dose rate (HDR) brachytherapy in locally advanced cervical cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Mahantshetty |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
1123, 11th floor,
Homi Bhabha building, Dr. Ernest Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177168 |
| Fax |
|
| Email |
drumeshm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Mahantshetty |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
1123, 11th floor,
Homi Bhabha building, Dr. Ernest Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177168 |
| Fax |
|
| Email |
drumeshm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Mahantshetty |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
1123, 11th floor,
Homi Bhabha building, Dr. Ernest Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177168 |
| Fax |
|
| Email |
drumeshm@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMC intramural fund, CRS
3rd floor, Main building,
Tata Memorial Hospital,
E Borges Marg,
Parel
Mumbai
400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
TMC intramural fund, CRS 3rd floor, Main building, Tata Memorial Hospital, E Borges Marg, Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Umesh Mahantshetty |
Tata Memorial Hospital |
Room no.1123, Homi Bhabha Building,
Dr. Ernest Borges
Marg, Parel, Mumbai -
400012
Mumbai
MAHARASHTRA |
022-24177168
drumeshm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cancer of Uterine Cervix, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Single application multi-fractionated high dose rate brachytherapy in cervical cancer |
Patient will receive external beam radiotherapy and if suitable concurrent chemotherapy as per standard of care. In the single application multi-fractionated high dose rate (HDR) brachytherapy each patient will receive 3 HDR fractions of which 1st, 2nd and 3rd fractions are 09 Gy, 07Gy and 07Gy respectively keeping 6-12 hours of interval. All patients will undergo an inter-fraction CT scan before delivery of second fraction. Plane will be re-optimized to reduce the dose to OAR’s, only if the dose exceeds the dose constraints. Dose constraints being exceedingly hard in 1st fraction itself will deem patient non-feasible and will receive standard fractions hereafter, while the same seen before 2nd fraction even after re-planning will also deem patient non-feasible but optimisation will be done to give preference to OAR’s while accepting some compromise in target doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1) Histologically diagnosed invasive cervical cancer (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma)
2) FIGO stage II B - IV A after thorough clinical examination and work-up investigation.
3) Suitable for radical radiation therapy with/without chemotherapy, and also for brachytherapy boost.
4)Accepts the Informed consent process and signs the form on his/her will.
|
|
| ExclusionCriteria |
| Details |
1)Patients with vesico-vaginal fistula or recto-vaginal fistula at diagnosis.
2)Patients at high risk of anaesthesia and patients with phobia /contra-indications to undergo MRI.
3)Patients not suitable for brachytherapy.
4)Metastatic disease beyond iliac on standard imaging.
5)Vault cancers/recurrence.
6)Previous history of pelvic radiation.
7)Non-compliance to treatment.
8)Medical or psychological illness precluding treatment protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To evaluate feasibility to achieve dosimetric constraints for target and organs at risk, thus safety to deliver multi-fractionated brachytherapy in a single application |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate inter fraction dose variation for organs at risk
|
1 year |
To assess clinical outcomes in terms of late Gastrointestinal (GI)/Genitourinary (GU)/vaginal toxicities (grade 3 or more) and local control rates.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/04/2017 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical cancer is a major health problem in developing world including India. Radical radiation therapy with / without concomitant chemotherapy is the treatment of choice for locally advanced cervical cancers. The primary advantage of 3D image guided brachytherapy over conventional 2D system is that it allows the dose to conform to the anatomy of each individual patient while reducing the dose to organs at risk. Our intention is to deliver fractionated treatments in a strict image based and quality controlled environment to minimize the doses to organs at risk. Evaluation of feasibility will be done in phase 1 and 2 setting. Dose constraints to organs at risk will be achieved concomitantly, keeping the inter fraction doses to organs at risk in account. This study is expected to increase ease and acceptability of brachytherapy in patients and with significant saving of resources |