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
|
|
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
|
|
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.
|