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CTRI Number  CTRI/2025/06/089176 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Faster radiation treatment for pelvic cancer patients with dose and side effects evaluation.  
Scientific Title of Study   Dosimetric assessment and clinical implementation of flattening filter- free (FFF) Volumetric Modulated Arc Therapy(VMAT) with toxicity evaluation in pelvic cancers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srinidhi G Chandraguthi 
Designation  Senior Grade Lecturer 
Affiliation  Kasturba Medical College Manipal/Manipal Academy of Higher Education 
Address  Department of Radiation Oncology Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal,Karnataka,India

Udupi
KARNATAKA
576104
India 
Phone  9731689095  
Fax    
Email  shrinidhi.gc@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Srinidhi G Chandraguthi 
Designation  Senior Grade Lecturer 
Affiliation  Kasturba Medical College Manipal/Manipal Academy of Higher Education 
Address  Department of Radiation Oncology Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal,Karnataka,India

Udupi
KARNATAKA
576104
India 
Phone  9731689095  
Fax    
Email  shrinidhi.gc@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Srinidhi G Chandraguthi 
Designation  Senior Grade Lecturer 
Affiliation  Kasturba Medical College Manipal/Manipal Academy of Higher Education 
Address  Department of Radiation Oncology Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal,Karnataka,India

Udupi
KARNATAKA
576104
India 
Phone  9731689095  
Fax    
Email  shrinidhi.gc@manipal.edu  
 
Source of Monetary or Material Support  
Department of Radiation Oncology,Kasturba Medical College,Kasturba Hospital,Manipal-576104 
 
Primary Sponsor  
Name  Department of Radiation Oncology,Kasturba Medical College,Kasturba Hospital,Manipal 576104 
Address  Department of Radiation Oncology,Kasturba Medical College,Kasturba Hospital,Udupi-Hebri Road,Manipal-576104 
Type of Sponsor  Private medical college 
 
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 
SRINIDHI G CHANDRAGUTHI  KASTURBA HOSPITAL  DEPARTMENT OF RADIATION ONCOLOGY KASTURBA MEDICAL COLLEGE KASTURBA HOSPITAL MANIPAL-576104 UDUPI KARNATAKA
Udupi
KARNATAKA 
9731689095

shrinidhi.gc@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C530||Malignant neoplasm of endocervix, (2) ICD-10 Condition: C541||Malignant neoplasm of endometrium, (3) ICD-10 Condition: C61||Malignant neoplasm of prostate, (4) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with pelvic cancer cervix, endometrium, rectum and prostate
2. Patient planned for radiation with radical intent- definitive, neoadjuvant or adjuvant.
3. Patients with performance status 0 to 2.
4. Patients with pelvic cancers diagnosed in stage I-IV.
 
 
ExclusionCriteria 
Details  1. Patients treated with SBRT.
2. Patients with prior history of radiotherapy.
3. Patients with metastatic cancer at presentation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The standard VMAT and FFF VMAT plans for pelvic cancers, focusing on dosimetric outcomes, planning, and delivery times. DVH parameters, including target coverage, OAR dose, and normal tissue exposure, will be analyzed. Derived indices (CI, HI, GI), planning time, beam-on time, and monitor units will be recorded. Patients will be included after informed consent and treated per standard protocols after approval by review   At baseline only. 
 
Secondary Outcome  
Outcome  TimePoints 
The acute toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at baseline, weekly during treatment, & post-treatment at one, three & 6 months. The quality of life will be assessed using EORTC QLQ C30 at baseline, radiotherapy completion, & post-treatment at one, three & 6 months.

The quality of life (QoL) of cancer patients will be assessed using the European Organization for Research & Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This assessment will be conducted at multiple points: baseline (before the start of radiotherapy), at the completion of radiotherapy, & post-treatment at one, three, & six months.
 
Acute Toxicity at baseline, weekly during treatment & at 1,3 & 6 months post treatment.

QoL at baseline,radiotherapy completion & 1,3 & 6months 
 
Target Sample Size   Total Sample Size="282"
Sample Size from India="282" 
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)   02/07/2025 
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="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  


Patients meeting the eligibility criteria will be screened for the study and included after informed consent. Patients with pelvic cancers considered for radiotherapy will be planned with two plans—standard VMAT and FFF VMAT with MCO. The planning time will be recorded for both techniques. All planned cases will be subjected to pretreatment review in terms of dose per fraction, monitor units, volume histogram analysis, conformity index, Homogeneity index for targets, and OARs dose parameters as per standard reports. The pretreatment review board will comprise of at least 2 senior radiation oncologists (>10 years’ experience) and one senior physicist. Based on the discussion, the best plan will be chosen for treatment. The comments of the review group will be prospectively recorded. The feasibility of choosing a FFF VMAT plan will be recorded prospectively over two years.

The standard VMAT and FFF VMAT plans will be compared in terms of dosimetric outcomes, planning time and delivery time (Monitor units). The DVH parameters such as target dose coverage, dose to OAR, and normal tissue with all VMAT plans, will be collected for each pelvic cases after approval, and derived values of Conformity index, HI for target, and Gradient index, treatment planning time, beam on time, monitor units will be recorded/estimated for analysis. The patients for whom Standard VMAT or FFF VMAT are approved will be included in the study after informed consent. The patients will receive treatment as per standard practice for the pelvic sites.

Patient specific quality assurance will be carried out for planned case prior to implementation. Point dose and Fluence maps from RTPS for all optimized plans will be transferred to pelvic phantom to deliver and to match delivered fluence against planned fluence with 3% 3mm criteria and 3% for point dose.

The implementation time for treatment delivery (treatment planning to treatment delivery including QA time) will be recorded.

The acute toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at baseline, weekly during treatment, and post-treatment at one, three and 6 months. The quality of life will be assessed using EORTC QLQ C30 at baseline, radiotherapy completion, and post-treatment at one, three and 6 months.

 

The quality of life (QoL) of cancer patients will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This assessment will be conducted at multiple points: baseline (before the start of radiotherapy), at the completion of radiotherapy, and post-treatment at one, three, and six months.

Baseline Assessment

At baseline, patients will complete the EORTC QLQ-C30 to establish their initial QoL status. This initial assessment will provide a reference point to measure changes in QoL over time.

Radiotherapy Completion

Upon completion of the radiotherapy treatment, patients will again complete the EORTC QLQ-C30. This assessment aims to capture the immediate effects of the treatment on the patients’ QoL, including any acute toxicities or immediate improvements.

Post-Treatment Assessments

Further assessments will be conducted at one, three-, and six-month post-treatment. These follow-up assessments are crucial for monitoring the long-term effects of the radiotherapy, including any late-onset side effects and the overall recovery process. The repeated measures allow for tracking the trajectory of QoL changes over time.

EORTC QLQ-C30 Components

The EORTC QLQ-C30 is a comprehensive tool that evaluates various dimensions of QoL, including Global health status/QoL: Overall perception of health and quality of life. Functional scales: Physical, role, emotional, cognitive, and social functioning.

Symptom scales/items: Fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.

Implementation

Patients will complete the EORTC QLQ-C30 through self-administration, with assistance available if needed. The data collected will be used to identify trends and patterns in QoL changes, helping to understand the impact of radiotherapy treatment on patients’ lives.

 


 
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