| CTRI Number |
CTRI/2025/05/086522 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving cervical cancer treatment with image guided brachytherapy |
|
Scientific Title of Study
|
Assessment of treatment outcomes using Image Guided Adaptive Brachytherapy (IGABT) for cervical cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Radiation oncology department ground floor OPD block AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
6377923585 |
| Fax |
|
| Email |
rahulnagar.work229@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A Kesava Ramgopal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Radiation oncology department ground floor OPD block AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9491331850 |
| Fax |
|
| Email |
kesav.rt@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Kesava Ramgopal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Radiation oncology departement ground floorOPD block AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9491331850 |
| Fax |
|
| Email |
kesav.rt@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Mangalagiri Guntur Andhra Pradesh 522503 |
|
|
Primary Sponsor
|
| Name |
Dr Rahul |
| Address |
AIIMS Mangalagiri Guntur Andhra Pradesh 522503 |
| Type of Sponsor |
Other [] |
|
|
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 Rahul |
AIIMS |
OPD block AIIMS Mangalagiri, Guntur , Andhra Pradesh
Guntur
ANDHRA PRADESH |
6377923585
rahulnagar.work229@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethiccommittee, aiims mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C530||Malignant neoplasm of endocervix, (2) ICD-10 Condition: C531||Malignant neoplasm of exocervix, (3) ICD-10 Condition: C538||Malignant neoplasm of overlappingsites of cervix uteri, (4) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Histologically confirmed diagnosis of cervical cancer (FIGO stages IB to IVA).
Patients planned for chemoradiotherapy followed by IGABT.
Patients who consent to imaging-based brachytherapy (MRI or CT).
Age: 18 years and above with ECOG performance status ECOG less than or equal to 2.
|
|
| ExclusionCriteria |
| Details |
History of prior pelvic irradiation
Pregnancy and lactation
Any contraindication for CT and MRI imaging
Poor performance status(ECOG more than 2)
Patients with coexisting malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of tumor outcomes using image guided brachytherapy |
Assessment at 1st month, 3rd month and 6th months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of IGABT on treatment related toxicity & patient quality of life |
at 1 month 3 month & 6 month |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
19/05/2025 |
| 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 Applicable |
| 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
|
Cervical cancer is the fourth most common cancer among women globally, particularly in low- and middle-income
countries where screening and vaccination programs are less accessible. According to the World Health Organization (WHO), there are approximately
570,000 new cases and 311,000 deaths from cervical cancer each year. Cervical cancer is primarily caused by persistent infection with high-risk human
papillomavirus (HPV) types, and the disease progresses through pre-cancerous lesions to invasive carcinoma if untreated..Brachytherapy (BT) is a
cornerstone in the management of locally advanced cervical cancer, especially for stages IB2 to IVA as per the FIGO classification. It involves the direct
placement of radiation sources within or near the tumor site, allowing high-dose radiation delivery to the tumor while sparing surrounding healthy tissues.
Brachytherapy has been shown to improve local control and survival rates, complementing external beam radiotherapy (EBRT) and chemotherapy as part
of a curative treatment regimen. Traditional 2D X-ray-based brachytherapy has limitations in terms of precision and the ability to adapt dose distributions
to the tumor’s shape and location. Conventional methods use predefined anatomical points (e.g., point A) as surrogates for tumor location, leading to dose
variability and inaccuracies, especially in large or irregularly shaped tumors. This often results in suboptimal dose delivery to the tumor, insufficient
sparing of surrounding organs-at-risk (OARs), and consequently, an increased risk of complications and recurrence. In response to the limitations of
conventional brachytherapy, Image-Guided Adaptive Brachytherapy (IGABT) has been developed as a more precise approach that incorporates imaging
to guide radiation placement. The technique uses MRI or CT imaging to delineate the tumor and surrounding structures in three dimensions, allowing for
individualized treatment planning and dose adaptation based on the tumor’s response to external beam radiation therapy (EBRT). IGABT allows higher
doses to the tumor while minimizing exposure to OARs like the bladder, rectum, and sigmoid colon, improving the therapeutic ratio.This study follows
the guidelines by GEC-ESTRO for target volume delineation, dose constraints, and adaptive planning in IGABT and evidences by EMBRACE on local
control and survival rates in cervical cancer patients by IGABT in comparison to conventional brachytherapy |