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CTRI Number  CTRI/2026/01/101317 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 29/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Radiation Therapy as SBRT]  
Study Design  Single Arm Study 
Public Title of Study   Safety Comparison of Two Radiation Approaches women Undergoing Chemoradiation for Cervical Cancer 
Scientific Title of Study   Stereotactic Body Radiotherapy (SBRT) boost versus Simultaneous Integrated Boost (SIB) to pelvic nodes among patients receiving radical chemoradiation in Carcinoma Cervix: A Prospective, pilot Study comparing safety profiles. 
Trial Acronym  PELICAN- SBRX Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR KARUN KAMBOJ 
Designation  Assistant Professor -Radiation Oncology (NCI) 
Affiliation  AIIMS New Delhi 
Address  Room no. 104, Ist Division, Department of Radiation Oncology, National Cancer Institute, AIIMS , Jhajjar
Room no. 104, Ist Division, Department of Radiation Oncology, National Cancer Institute, AIIMS , Jhajjar
Jhajjar
HARYANA
122017
India 
Phone  9416613389  
Fax    
Email  karunkamboj04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. KARUN KAMBOJ 
Designation  Assistant Professor -Radiation Oncology 
Affiliation   
Address  Room no. 104, Ist Division, Department of Radiation Oncology, National Cancer Institute, AIIMS , Jhajjar

Jhajjar
HARYANA
122017
India 
Phone  9416613389  
Fax    
Email  karunkamboj04@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR. KARUN KAMBOJ 
Designation  Assistant Professor -Radiation Oncology (NCI) 
Affiliation  AIIMS New Delhi 
Address  Room no. 104, Ist Division, Department of Radiation Oncology, National Cancer Institute, AIIMS , Jhajjar

Jhajjar
HARYANA
122017
India 
Phone  09416613389  
Fax    
Email  karunkamboj04@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi – 110029 Delhi, India Country: India Pincode: 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  All India Institute of Medical Sciences (AIIMS), New Delhi, India (Pincode 110029) 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 KARUN KAMBOJ  National Cancer Institute, AIIMS, Jhajjar  Clinical Assessment Room, Department of Radiation Oncology, Basement Division, OPD Block, National Cancer Institute, All India Institute of Medical Sciences (AIIMS), Jhajjar, India (Pincode 124103).
Jhajjar
HARYANA 		 9416613389

karunkamboj04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, New Delhi  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 
Comparator Agent  Arm A  Comparator Arm (Arm A): Simultaneous Integrated Boost (SIB) to pelvic nodes delivered at 55 Gy in 25 fractions alongside radical chemoradiation for carcinoma cervix 45Gy in 25 fractions over 5 weeks followed by Brachytherapy.  
Intervention  Arm B  Intervention Arm (Arm B): Stereotactic Body Radiotherapy (SBRT) boost to pelvic nodes at 14 Gy in 2 fractions delivered over the 1st and 2nd week alongside standard radical chemoradiation (45 Gy in 25 fractions over 5 weeks) for carcinoma cervix followed by Brachytherapy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Patients aged 18 years or older with locally advanced cervical cancer suitable for primary treatment with chemoradiotherapy.
Pathologically confirmed carcinoma cervix squamous,adenocarcinoma,adeno-squamous carcinoma histology.
Patients with stage IIIC disease, who have not undergone previous pelvic radiation therapy or surgery and have an Eastern Cooperative Oncology Group performance status of 0-2.
Patients diagnosed with cervical cancer with pelvic nodal burden less than 3cm or 30cc up to 4 lymph nodes who are eligible for chemo-radiotherapy.
Signed informed consent.
Adequate end organ function hepatic, renal, cardiac reserve 
 
ExclusionCriteria 
Details  Patients with stage I or stage II or stage IV disease
Patients with prior malignancies or active autoimmune diseases will be excluded from the study.
Other histology melanoma, small cell, basal cell carcinoma
Previous pelvic radiotherapy, hysterectomy, any form of oncological treatment.
Contraindications to CEMRI, brachytherapy
Age less than 18 years.
Uncontrolled medical comorbidity. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to compare the safety profile of SBRT boost vs SIB to pelvic nodes among
patients with Stage III-C carcinoma cervix by assessing the acute GI and GU toxicity (Grade 3
GI/GU toxicity) within 30 days of completion of treatment. 		 The toxicity will be assessed at the following time points: baseline, 4 weeks, 3 months, and 6 months post-treatment completion. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the dosimetry of organs at risk between the two study arms.
ï‚· To evaluate the efficacy of SBRT in terms of local control using radiological imaging by
assessing the response rates, post-treatment (3 months) using RECIST, PERCIST Criteria 		 3 months 
NIL  NIL 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
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)   06/03/2026 
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)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
I am writing to request the registration of our clinical trial, "Stereotactic Body Radiotherapy (SBRT) Boost versus Simultaneous Integrated Boost (SIB) to Pelvic Nodes among Patients Receiving Radical Chemoradiation in Carcinoma Cervix: A Prospective, Pilot Study Comparing Safety Profiles," under CTRI. 
I request your assistance in facilitating the registration process under the CTRI for this study to contribute valuable insights into optimising radiotherapy approaches in carcinoma cervix management.
 
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