| CTRI Number |
CTRI/2024/06/068698 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [NACT with chemotherapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of chemotherapy along with radiation in advanced carcinoma of cervix after induction chemotherapy in rural india |
|
Scientific Title of Study
|
A pilot study assessing the role of induction chemotherapy followed by chemo radiation in locally advanced cervical cancer in a tertiary care hospital in central rural India |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanchan Dasharthrao Devde |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of higher education and research centre |
| Address |
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788760080 |
| Fax |
|
| Email |
drkanchandevde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Dongre |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of higher education and research centre |
| Address |
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9322978781 |
| Fax |
|
| Email |
amolpgi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan Dasharthrao Devde |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of higher education and research centre |
| Address |
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788760080 |
| Fax |
|
| Email |
drkanchandevde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kanchan Devde
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha India
Pin code 442001 |
|
|
Primary Sponsor
|
| Name |
Siddharth gupta memorial hospital |
| Address |
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha India
pin code 442001 |
| 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 |
| Dr Kanchan Devde |
Jawaharlal Neharu Medical College |
Room no 101 Department of Medical Oncology Siddhartha Gupta Memorial JNMC AVBRH DMIMS Sawangi
Meghe Wardha India
pin code 442001
Wardha
MAHARASHTRA |
8788760080
drkanchandevde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of higher education |
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 |
Neoadjuvent chemotherapy with inj paclitaxel and inj carboplatin |
Patients with stage III and IV procceds bt giving NACT with chemotherapy drug regimen injection paclitaxel 80mg per meter aquare and inj carboplatin Area Under Curve 2 weekly for 6 cycle for 44 days after that patient will plan for chemoradiation with concurrent cisplatin 40 mg per meter square then response assessment total duration of 3 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Age more than 18 year
ECOG 0/1
Good renal, hepatic and CBC
Women with biopsy proven squamous, adeno or adenosquamous carcinoma
Stage III and IVA FIGO (2018)
|
|
| ExclusionCriteria |
| Details |
Patients with early stage cancer stage I and II
metastaic disease at presentation autoimmune disease patient who not willing for study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| progression free survival in FIGO stage III and IVa patient after giving NACT |
progression free survival in FIGO stage IIIand IVa patient after giving NACT after 8week of completion of radiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| progression free survival |
At baseline |
| radiation side effect compliance and tolerabilty |
baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="1"
Months="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
After approval from the Institutional Ethics Committee, A pilot study will be conducted in MEDICAL ONCOLOGY and RADIATION ONCOLOGY Department of SGMCH unit of department of Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of Wardha District, Maharashtra, India. At first contact with the patient, a detailed history and clinical evaluation of the patient shall be done. Clinical examination and a biopsy from the cervical lesion shall be taken and any previous treatment will be ascertained.
|