| CTRI Number |
CTRI/2024/04/066094 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the practical usage, safety and efficiency of PET CT in dose optimization for radiotherapy treatment in locally advanced cervix carcinoma. |
|
Scientific Title of Study
|
Assessing the feasibility, toxicities and efficacy of 18-FDG PET CT guided dose optimization for radiotherapy treatment in locally advanced cervix carcinoma- A Prospective Phase 2, Pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Sadasivam |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Department of Radiation Oncology,
Building 7, Regional Cancer Centre,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
07904092132 |
| Fax |
|
| Email |
pradeep.sadasivam96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Sethi |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Department of Radiation Oncology,
Building 7, Regional Cancer Centre,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9543601257 |
| Fax |
|
| Email |
docpujasethi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Sethi |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Department of Radiation Oncology,
Building 7, Regional Cancer Centre,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9543601257 |
| Fax |
|
| Email |
docpujasethi@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Jawaharlal Institute of Postgraduate Medical Education and Research
HOSPITAL
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
|
|
|
Primary Sponsor
|
| Name |
The Jawaharlal Institute of Postgraduate Medical Education Research |
| Address |
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Pradeep Sadasivam |
The Jawaharlal Institute of Postgraduate Medical Education and Research Hospital |
Department of Radiation Oncology,
Regional Cancer Centre
Pondicherry
PONDICHERRY |
7904092132
pradeep.sadasivam96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Jawaharlal Institute of Postgraduate Medical Education and Research INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Image guided Adaptive Brachy therapy using information with PET CT |
Dose de-escalation to CTV-HR (Total dose up to 85Gy) will be considered if Change in SUVmax more than or equal to 50% from baseline (SUVmax Baseline-SUVmax at first Brachytherapy session) and MTV is less than 30cc. (Both criteria met)
If anyone criterion only met moderate dose will be considered i.e. EQD2 between 85-90 Gy depending upon tolerance of OARs.
If both criteria not met but the tumor volume can be encompassed with intracavitary brachytherapy (i.e. less than 4cm) then it will be tried for dose escalation between 90- 95 Gy as per the tolerance allowed for OARs. (Otherwise will be considered for IC along with IS brachytherapy) |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Treatment naïve,
2. histopathologically proven carcinoma cervix (squamous/adeno/adeno-squamous),
3. International Federation of Gynecology and Obstetrics (FIGO) (2018) stage 1B-IIIC2 patients,
4. age 18-60 years,
5. attending gynecological tumor clinics, with ECOG performance status 0-2,
6. with adequate organ function and planned for definitive treatment with chemoradiotherapy and intracavitary brachytherapy.
7. Adequate organ function at time of participation
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled Diabetes mellitus, hypertension
2. Patients with HIV infection, Hepatitis B/C infection/ Active Tuberculosis/ any other systemic infection
3. Previously any pelvic surgery / partial or total hysterectomy
4. Previous pelvic/ abdominal radiotherapy
5. Patients with history of neoadjuvant chemotherapy
6. Patients with history of allergy to iodinated contrast or 18F-FDG
7. Patients requiring ISBT post external beam radiotherapy treatment
8. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
9. Pregnancy
10. Patients with bladder or rectal invasion at diagnosis, vesico-vaginal fistula, or recto-vaginal fistula at diagnosis or post EBRT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess proportions of patients achieving hard dose constraints for target and OAR Doses
To assess the proportions of patients developing grade 3 acute toxicity during or till 3 months post treatment |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess PET based disease remission status at 3 months
To assess the proportions of patients developing more than grade 3 late toxicities at 6 months and at 1 year
To assess disease free survival at 1 year
To assess proportions of patients achieving soft constraints for target and OAR Doses
To assess Change in EORTC-QOL score from baseline to 3 months, 6 months and 1 year post treatment. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
30/04/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pradeep.sadasivam96@gmail.com].
- For how long will this data be available start date provided 30-04-2024 and end date provided 30-04-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Project title is Assessing the feasibility, toxicities and efficacy of 18-FDG PET CT guided dose optimization for radiotherapy treatment in locally advanced cervix carcinoma- A Prospective Phase 2, Pilot study
External beam pelvic radiotherapy with concurrent cisplatin-based chemotherapy and brachytherapy is standard of care for locally advanced uterine cervical cancer (LAUCC). Recently several studies have investigated the use of image-guided brachytherapy in cervical cancer, which help in optimizing radiation doses to post external beam radiotherapy target volume while minimizing normal tissue toxicity using three dimensional (3D) brachytherapy planning. Magnetic resonance imaging (MRI)-guided planning can give the best soft tissue resolution and is the method of choice for image-based brachytherapy; however, its use is limited by MRI availability and lack of availability of MR-compatible applicators, and the inability to use MRI guided planning in patients with metallic implants. Some studies have been done utilizing metabolic tumor volume information from 18-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging for dose adaptation or dose escalation in LAUCC radiation planning. Many authors published regarding the use of FDG-PET with or without CT in brachytherapy planning, and the results of these studies demonstrated the feasibility of planning based on FDG-PET. Moreover PET gives additional baseline information about regional, distant metastases for staging purpose as well as information on metabolic treatment response post chemoradiotherapy. Recently Kim et al. reported its prognostic significance also in terms of poor disease-free survival and overall survival if post external beam radiotherapy, patients had change in tumor SUVmax (maximum standardized uptake value) less than 50% from baseline. In this study, we want to assess the feasibility toxicities and efficacy by using FDG-PET/CT guided dose-volume optimization of most commonly prescribed fractionation regimen in our department for pelvic external beam radiotherapy and brachytherapy in LAUCC. To assess the feasibility toxicities and efficacy by using FDG-PET/CT guided dose-volume optimization of most commonly prescribed fractionation regimens in our department in LAUCC. There is limited experience on PET Guided Radiotherapy specially IGBT in India. FDG-PET/CT guided dose-volume optimization in LAUCC is feasible, tolerable and efficacious and it can be considered as an alternative to MR guided image guided brachytherapy reported in literature. |