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CTRI Number  CTRI/2025/08/093607 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Outcomes of Radiotherapy and Chemotherapy in operated patients of Carcinoma Cervix with residual or recurrent disease 
Scientific Title of Study   Outcomes of Salvage Chemoradiotherapy followed by brachytherapy in carcinoma cervix patients following inadequate hysterectomy with residual or recurrent disease in a tertiary care oncology centre (SCORE Study)  
Trial Acronym  SCORE study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SATYAJIT PRADHAN 
Designation  Professort Radiation Oncology  
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre Unit of Tata Memorial Centre  
Address  Directors Office 5th Floor DNT Block MPMMCC Sundar Bagiya Sunderpur VaranasiVaranasi Varanasi UTTAR PRADESH 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415228261  
Fax    
Email  Satyajit.pr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SATYAJIT PRADHAN 
Designation  Professort Radiation Oncology  
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre Unit of Tata Memorial Centre  
Address  Directors Office 5th Floor DNT Block MPMMCC Sundar Bagiya Sunderpur VaranasiVaranasi Varanasi UTTAR PRADESH 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415228261  
Fax    
Email  Satyajit.pr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SATYAJIT PRADHAN 
Designation  Professort Radiation Oncology  
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre Unit of Tata Memorial Centre  
Address  Directors Office 5th Floor DNT Block MPMMCC Sundar Bagiya Sunderpur VaranasiVaranasi Varanasi UTTAR PRADESH 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415228261  
Fax    
Email  Satyajit.pr@gmail.com  
 
Source of Monetary or Material Support  
Homi Bhabha Cancer Hospital, Shivpurva, Varanasi, Uttar Pradesh, India, 221002 
 
Primary Sponsor  
Name  Homi Bhabha Cancer Hospital & Mahamana Pandit Madan Mohan Malaviya Cancer Centre 
Address  Homi Bhabha Cancer Hospital & Mahamana Pandit Madan Mohan Malaviya Cancer Centre 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Aditya Gyanasagar  Homi Bhabha Cancer Hospital (HBCH)  Radiation Oncology Department, Ground Floor, Old Loco Colony, Shivpurwa, Varanasi
Varanasi
UTTAR PRADESH 
8637299930

adityagyana23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MPMMCC and HBCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  - Carcinoma of Cervix Uteri with residual and/or recurrent disease following inappropriate surgery.
- Histopathological proof of Squamous cell carcinoma, adenocarcinoma or adeno-squamous carcinoma
- Patients being treated with curative intent using concurrent chemo-radiotherapy (CTRT) followed by
brachytherapy.
- ECOG PS 1-2
- Patient consenting for participation in study (Written informed consent for prospective patients, Telephonic informed consent for retrospective patients) 
 
ExclusionCriteria 
Details  - Presence of distant metastases.
- Medical condition precluding curative intent treatment for the patient.
- History of previous treatment for the present condition.
- Patients with immunocompromised states and psychological illness.
- Pregnant or lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Disease free survival (DFS)  1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
Acute and Late treatment toxicities based on CTCAE v5.0 toxicity criteria  1 Year 
Overall Survival (OS)  1 Year 
Radiological response as per RECIST V1.1  6 months  
Pattern of Failure   1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   03/09/2025 
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="1"
Months="6"
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  
Cervical cancer poses a significant global health issue, particularly in low- and middle-income countries, with 660,301
new cases and 348,874 deaths annually, as per GLOBOCAN 2022. (1) Cervical cancer is the second most common
cancer amongst women in the South East Asian region, and it is a major cause of cancer mortality in low and middle-
income nations. (2) China and India jointly add to more than a third of the worldwide cervical burden, with 48,000
deaths in China and over 60,000 deaths in India alone (3) .
Early cervical cancer is typically asymptomatic, emphasizing the significance of screening. It may be identified in
asymptomatic patients during cancer screening or by chance if a visible lesion is identified during a pelvic
examination (4) . At diagnosis, approximately 44 percent of patients have localized disease, 34 percent have regional disease, and
15 percent have distant metastases (5) .
The majority of cervical malignancies (80-90 percent) are invasive squamous cell tumors, with 10-20 percent being
adenocarcinoma and clear cell cancers constituting 1-2 percent of all cases (6) . Locally Advanced Cervical Cancer (LACC)
is a common presentation in India. LACC can be defined based on FIGO Staging 2018, that include Stage IIb to IIIC1.
The risk of pelvic LN involvement is around 15 percent, 30 percent, and 45 percent for stage I, II, and III illness, respectively.
Treatment outcomes are determined by the stage of the disease at presentation, and the prognosis worsens with an
increasing disease load. Nearly one-third of patients with cervical carcinoma will have a recurrence (7,8) .
Treatment of cervical cancer, in general, depends on the extent of the disease at diagnosis and available local
resources. The treatment may employ radical hysterectomy, chemoradiation, or a combination of both (9) . However,
for LACC, Radiation therapy (RT) has been the main treatment option (10) . Most women with early-stage tumors can
be cured. External beam radiotherapy (EBRT), brachytherapy, and concurrent chemotherapy with cisplatin are used to
treat cervical cancer with curative intent (11) . Several randomized controlled trials (RCTs) and meta-analyses have
shown that concurrent CTRT improves progression-free survival (PFS) and overall survival (OS) (12,13) .
Brachytherapy is an important part of the standard of care for patients receiving radiotherapy for cervical cancer.
Despite the availability of standard treatment options for cervical cancer, challenges persist, particularly with
inappropriate surgery. An inadequate or inadvertent hysterectomy refers to a surgical procedure where the extent of
the surgery is insufficient to remove all cancerous tissue, often due to incorrect preoperative staging or lack of
awareness of the extent of disease spread, lack of expertise and knowledge of oncologic practices. This leads to
residual disease after surgery and disease progression. There is also a significant increase in the risk of recurrence after
inadequate surgery that compromises treatment outcomes. Residual disease and recurrence can result in the need for
additional treatments, such as chemo radiotherapy or brachytherapy, which can impact patient prognosis, quality of
life, and survival.
Despite the established role of concurrent chemoradiotherapy (CTRT) and Brachytherapy in cervical cancer
management, there still remains a paucity of literature specifically addressing their efficacy and optimal utilization in
the context of inappropriate surgery. Studies have focused on definitive treatment settings or adjuvant therapy
following radical surgery, leaving a knowledge gap regarding the nuances of managing patients with a residual or
recurrent disease following inadequate surgery. In this part of the country a large number of cancer cervix patient
present to the oncology centers with residual/recurrent disease following inappropriate surgery.
The present ambispective study that involves radiotherapy with concurrent chemotherapy followed by brachytherapy
is being taken up in patients of cervical cancer with residual and recurrent disease following inappropriate surgery
with an intent to look at patterns of care, survival, and toxicity, that will help establish an evidence-based role of adjuvant therapy, in this group of patients.
 
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