| CTRI Number |
CTRI/2022/09/045315 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the Feasibility Study of the Tumour Specific Electroporation (TSE) Technique in Patients with Locally Advanced or Recurrent Head & Neck Cancer |
|
Scientific Title of Study
|
A Clinical Applicability Study of the Tumour Specific Electroporation Technique for Patients with Locally Advanced or Recurrent Head & Neck Cancer Using IQwave 3.0 CE. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeewan Ram Vishnoi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Surgical Oncology, OPD Block, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09455061569 |
| Fax |
|
| Email |
drjvishnoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeewan Ram Vishnoi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Surgical Oncology, OPD Block, All India Institute of Medical Sciences, Jodhpur
RAJASTHAN
342005
India |
| Phone |
09455061569 |
| Fax |
|
| Email |
drjvishnoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeewan Ram Vishnoi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Surgical Oncology, OPD Block, All India Institute of Medical Sciences, Jodhpur
RAJASTHAN
342005
India |
| Phone |
09455061569 |
| Fax |
|
| Email |
drjvishnoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| India Sweden Healthcare Innovation Centre,
AIIMS Jodhpur |
| Scandinavian ChemoTech AB |
|
|
Primary Sponsor
|
| Name |
India Sweden Healthcare Innovation Centre |
| Address |
All India Institute of Medical Sciences, Basni Phase 2, Jodhpur |
| Type of Sponsor |
Other [India-Sweden Collaboration ] |
|
|
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 |
| Jeewan Ram Vishnoi |
Department of Surgical Oncology, AIIMS Jodhpur |
Department of Surgical Oncology, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN |
919455061569
drjvishnoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tumour Specific Electroporation |
Tumour Specific Electroporation Technique for patients with locally advanced or recurrent Head & Neck cancer using IQwave 3.0 CE. Patients who meet the eligibility criteria shall be enrolled on this study. Each patient will be subjected to receive a minimum of two (2) cycles of TSE treatments with an interval of 7-14 days between two treatments during a total study duration of 12 months (including follow-up). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients greater than or equal to 18 years of age.
2. Any gender of the patient
3. Histologically confirmed, Recurrent or progressive locally advanced Head & Neck cancers.
4. Primary tumors do not respond to the available standard of care treatments or are exhausted from chemotherapy and radiation, and are not amenable to surgery.
5. Patients with primary tumors but medically unfit for any standard treatment
6. Patient in a physical condition suitable for general anesthesia/local anesthesia
7. A life expectancy of at least six months.
8. Patients with an ECOG performance of less than 3.
9. Signed informed consent document. |
|
| ExclusionCriteria |
| Details |
1. Patients who have an extensive and rapidly progressive disease with poor performance status (ECOG > 3) and with a life expectancy of fewer than 3 months.
2. Patients with tumors seated deeper than three cm from the surface of the skin.
3. Patients who, for medical reasons, cannot be given bleomycin.
4. Patients with pre-existing pulmonary disease (COPD).
5. Patients with implanted devices such as pacemakers or insulin pumps.
6. If the tumors are located or directly attached to larger blood vessels. (Read IFU of IQwave electroporation device for more information).
7. Patients with brain metastases treated with surgery and or/radiotherapy who have progressive disease in the brain.
8. Pregnant or lactating women.
9. A prior cumulative dose of bleomycin exceeding 400 U.
10. Less than 14 days from previous cancer treatment (either local or systemic).
11. Chronic renal failure (Sr. Creatinine > 150 µmol/L).
12. An inadequate liver function is defined as:
a. AST or ALT greater than 2.5 x ULN in the absence of liver metastases or greater than 5 in the presence of liver metastases.
b. Bilirubin greater than 2 x ULN (except in the case of Gilberts Syndrome)
13. Inadequate bone marrow reserve is defined as:
a. White blood cell counts less than 3 x 10 /l or Neutrophil count less than 1.5 x 10/ l.
14. Patient unable, unwilling, or not in a mental stage to comply with the study protocol. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate tumor size reduction after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE. |
1. 3 months
2. 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the improvement of the patient’s quality of life (QOL) and to assess the patient’s immunological response after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE. |
6 months after first treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/09/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [drjvishnoi@gmail.com].
- For how long will this data be available start date provided 01-11-2024 and end date provided 01-11-2028?
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
|
This is an academic-driven project. India-Sweden Healthcare Innovation Centre has onboarded its technology partner Scandinavian ChemoTech AB. This is a post-market clinical follow-up study (PMCF), a single-arm, non-randomized study with 30 patients presented with locally advanced head and neck cancer, aiming to reduce tumor size and improve the patient’s quality of life (QOL). Patients who meet the eligibility criteria shall be enrolled in this study. Each patient will be subjected to receive a minimum of two cycles of TSE treatments. |