| CTRI Number |
CTRI/2024/09/074468 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of G-CSF in preventing oral ulcers in cancer patients receiving radiation therapy.
|
|
Scientific Title of Study
|
Effect of granulocyte colony stimulating factor (G-CSF) in prevention of radiation induced oral mucositis in patients receiving chemo-radiotherapy for head and neck cancer.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEVAL GUPTA |
| Designation |
PG resident |
| Affiliation |
VMMC AND Safdarjung hospital |
| Address |
Room no. 266, 2nd floor, OPD building, VMMC and Safdarjung hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9555577777 |
| Fax |
|
| Email |
DEVALGUPTA97@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Kapil Suri |
| Designation |
Professor |
| Affiliation |
VMMC AND Safdarjung hospital |
| Address |
Room no. 272, 2nd floor, OPD building, VMMC and Safdarjung hospital
New Delhi
DELHI
110029
India |
| Phone |
9810623205 |
| Fax |
|
| Email |
dudes@Live.in |
|
Details of Contact Person
Public Query
|
| Name |
DEVAL GUPTA |
| Designation |
PG resident |
| Affiliation |
VMMC AND Safdarjung hospital |
| Address |
VMMC and Safdarjung hospital, Ansari Nagar West New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9555577777 |
| Fax |
|
| Email |
DEVALGUPTA97@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital |
| Address |
SAFDARJUNG HOSPITAL ANSARI NAGAR WEST NEW DELHI- 110029 |
| 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 DEVAL |
VMMC and SAFDARJUNG HOSPITAL |
Room no. 266, 2nd floor, OPD building,
Deptt of radiation oncology,
Safdarjung Hospital
New Delhi
DELHI |
01126190763
devalgupta97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi-110029 |
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 |
| Intervention |
granulocyte-colony stimulating factor (G-CSF) |
G-CSf will be administered daily on days of radiation therapy at 2 ug/kg dose subcutaneously |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age more than 18 years, and are histologically proven case of squamous cell carcinoma of head and neck with ECOG performance status of 0-2.
Patients who have received a radiation dose of 10Gy to head and neck area during current chemo-radiotherapy treatment. |
|
| ExclusionCriteria |
| Details |
Patients with recurrent or metastatic disease or second primary.
Prior irradiation to head and neck area.
History of anaphylaxis to G-CSF injection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To ascertain the efficacy of granulocyte-colony stimulating factor (G-CSF) by
studying the incidence of grade III/IV oral mucositis, using RTOG criteria |
weekly during the course of radiation therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the time of onset & duration for healing of grade III & IV oral mucositis. |
Weekly during the course of radiation therapy |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/10/2024 |
| 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="0" |
|
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
|
It is an interventional study. Patients will have to give detailed clinical history and undergo clinical examination with evaluation of the primary tumour, nodes and metastasis. Radiation dose will be 66-70 Gy as total dose, with 2Gy in each fraction given over 5 consecutive days. Chemotherapy will be given as weekly intravenous cisplatin (40mg/m2) as per standard protocol. Patients who have received radiation dose of 10 Gy, will be administered 2µg/kg/day subcutaneously of granulocyte-colony stimulating factor (G-CSF) in the unirradiated normal skin daily till the end of radiation therapy. Patients will be assessed with daily clinical examination, to grade oral mucositis using RTOG criteria(8), and weekly blood tests. |