| CTRI Number |
CTRI/2024/04/066444 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [procedure trial] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Intra-arterial presurgery Chemotherapy in the management of advance staged oral cancer. |
|
Scientific Title of Study
|
Role of Intra-arterial Neoadjuvant Chemotherapy in the management of advance staged oral squamous cell carcinoma. |
| 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 Anand Gupta |
| Designation |
Associate Professor |
| Affiliation |
Govt medical college hospital Chandigarh |
| Address |
D-276, Block D, Level II, Department of Dentistry, Government medical college hospital (GMCH), Sector- 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646320601 |
| Fax |
|
| Email |
dranandkgmc2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Gupta |
| Designation |
Associate Professor |
| Affiliation |
Govt medical college hospital Chandigarh |
| Address |
D-276, Block D, Level II, Department of Dentistry, Government medical college hospital (GMCH), Sector- 32
CHANDIGARH
160030
India |
| Phone |
9646320601 |
| Fax |
|
| Email |
dranandkgmc2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Gupta |
| Designation |
Associate Professor |
| Affiliation |
Govt medical college hospital Chandigarh |
| Address |
D-276, Block D, Level II, Department of Dentistry, Government medical college hospital (GMCH), Sector- 32
CHANDIGARH
160030
India |
| Phone |
9646320601 |
| Fax |
|
| Email |
dranandkgmc2@gmail.com |
|
|
Source of Monetary or Material Support
|
| DST&RE Chandigarh Administration
Paryavaran Bhawan, 1st Floor, Sector 19-B, Madhya Marg, Chandigarh, India, 160030 |
|
|
Primary Sponsor
|
| Name |
Department Of Science Technology and renewable energy chandigarh |
| Address |
paryavaran bhawan, sector- 19 B, Chandigarh |
| Type of Sponsor |
Government funding agency |
|
|
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 Anand Gupta |
Government Medical College Hospital |
D-276, Block D, Level II, Department of Dentistry, Government medical college hospital (GMCH), Sector- 32
Chandigarh
CHANDIGARH |
9646320601
dranandkgmc2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra-arterial chemotherapy |
Cisplatin, a chemotherapeutic agent, will be given through the intra-arterial route in the Cath lab. It will be given in 3 weekly cycles. Two to three cycles will be given according to the response. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with confirmed diagnosis of advanced-stage (IVa/IVb) OSCC and surgically inoperable
2. Patients aged 18–80 years old will be included in the study.
3. Patients expected to comply with the protocol
4.Patient willing to enroll in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of previous treatment (surgery, chemotherapy, or radiotherapy) of oral cancer.
2. Pregnant patient, lactating mother or planning to be pregnant
3. Drug abusers or any other substance abuse
4. Patient with any psychiatric disorder or undergoing any psychiatric treatment
5. Patients with terminal illness whose prognosis of survival is less than a year |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and radiological response to chemotherapy. |
Pre-intervention,
2 weeks after the second cycle of chemotherapy,
2 weeks after 3rd Cycle (if given) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Toxicity assessment
Histopathological response. |
2 weeks after completion of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/05/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This prospective pilot study focuses on the shrinkage of disease/tumor in non-operable advance staged oral squamous cell carcinoma (mouth cancer). The chemotherapy drugs will be given through intra-arterial (IA) route as compared to standard approach of giving drugs through intravenous route (IV). The advantage of given intra-arterial drug is that the drugs will be delivered directly to the tumour site which is likely to have better chance of shrinkage as compared to IV route where drug is given in to the whole system and then drug distributes to whole body including tumor site. By doing this approach we have to go through artery in leg to reach the targeted site at face. This procedure will be performed in sterile and controlled environment at Cath lab. This will be performed by experts and patients will be followed up as mentioned in the research protocol. We intend to check the feasibility and outcome of this procedure. |