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CTRI Number  CTRI/2026/04/109332 [Registered on: 24/04/2026] Trial Registered Prospectively
Last Modified On: 23/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Single Arm Study 
Public Title of Study   A Study of a New Radiation Method to Treat Big Liver Tumors 
Scientific Title of Study   A Phase 2 Trial of Spatially Fractionated Radiotherapy for Large Hepatocellular Carcinoma (LATTICE-HCC) 
Trial Acronym  LATTICE-HCC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Khosla 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER) 
Address  Room No 28 Ground Floor Nehru Hospital Extension PGIMER Chandigarh
Ground Floor Department of Radiotherapy & Oncology PGIMER Sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  9876638478  
Fax    
Email  dr_divya_khosla@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya Khosla 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER) 
Address  Room No 28 Ground Floor Nehru Hospital Extension PGIMER Chandigarh
Ground Floor Department of Radiotherapy & Oncology PGIMER Sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  9876638478  
Fax    
Email  dr_divya_khosla@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Divya Khosla 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER) 
Address  Room No 28 Ground Floor Nehru Hospital Extension PGIMER Chandigarh
Ground Floor Department of Radiotherapy & Oncology PGIMER Sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  9876638478  
Fax    
Email  dr_divya_khosla@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Post Graduate Institute of Medical Education and Research Chandigarh, Sector 12-160012 
Type of Sponsor  Research institution and hospital 
 
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 Divya Khosla  Post Graduate Insttute of Medical Education and Research  Room No 29, Nehru Hospital Extension Ground Floor Chandigarh Sector 12-160012
Chandigarh
CHANDIGARH 		 09876638478

dr_divya_khosla@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C220||Liver cell carcinoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  None 
Intervention  Spatially Fractioned Radiotherapy using LATTICE technique  Patients will receive Spatially Fractionated Radiotherapy using Lattice Technique delivered with Volumetric Modulated Arc Therapy. The peripheral planning target volume will receive 20 Gy in 5 fractions with simultaneous integrated boost of 35 to 40 Gy to lattice vertices within the gross tumor volume. Treatment will be delivered on alternate days over two weeks with daily image guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  eighteen years and above, largest tumor diameter more than 8 cm, Child Pugh Class A or B7 
 
ExclusionCriteria 
Details  Extrahepatic disease, Prior radiotherapy to the liver, Diffuse or multifocal disease with no dominant lesion, life expectancy more than three months

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This prospective study evaluates feasibility, setup accuracy, and early outcomes of multi-fraction SFRT in large, unresectable hepatocellular carcinoma. Patients receive advanced radiotherapy. Outcomes at baseline, 4 and 8 weeks include feasibility, delivery accuracy, tumor response, and toxicity, generating evidence on safety, effectiveness, and its role in Indian practice.  Outcomes will be assessed at predefined intervals: at baseline (before treatment), and at 4 weeks and 8 weeks following completion of radiotherapy to evaluate early response and safety. 
 
Secondary Outcome  
Outcome  TimePoints 
Progression free survival assessed from start of radiotherapy to disease progression or death assessed up to 24 months  24 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 2 
Date of First Enrollment (India)   05/05/2026 
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)   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  
Hepatocellular carcinoma is a common liver cancer and many patients present with large unresectable tumors that are not suitable for surgery transplantation or other local therapies. Radiotherapy has become an important treatment option but dose escalation is limited because of the risk of liver toxicity and damage to surrounding organs.

Spatially fractionated radiotherapy using a lattice technique is a modern radiotherapy approach that delivers higher radiation doses to selected regions within the tumor while maintaining a lower dose to the surrounding tissue. This method may improve tumor response while reducing toxicity to normal liver tissue.

This prospective single arm phase two study will evaluate the safety feasibility and clinical outcomes of spatially fractionated radiotherapy in patients with large unresectable hepatocellular carcinoma. A total of twenty patients fulfilling the eligibility criteria will be treated using volumetric modulated arc therapy based lattice radiotherapy.

The primary objective is to assess local tumor control at six months after treatment. Secondary objectives include evaluation of progression free survival overall survival treatment related toxicity changes in liver function and quality of life. Patients will be followed with clinical examination laboratory tests and imaging studies during and after treatment.

The results of this study may help determine the role of spatially fractionated radiotherapy as a treatment option for patients with large hepatocellular carcinoma in the Indian clinical setting.
 
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