| CTRI Number |
CTRI/2021/09/036296 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
04/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral Chemotherapy for advanced head and neck cancer. |
|
Scientific Title of Study
|
Triple metronomic therapy versus physician choice chemotherapy after failure of platinum-based therapy in squamous cell head and neck cancer: A phase 3 randomized open-label study |
| Trial Acronym |
Triple OMCT study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC project No. 11000506 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Kapoor |
| Designation |
Assistant professor Medical oncology |
| Affiliation |
MPMMCC HBCH Varanasi |
| Address |
Room No 28, Department of Medical Oncology, Mahamana Pandit Madan Mohan Cancer Centre Sunderpur Varanasi
Room No. 6, Department of Medical Oncology, Old Loco Colony Shivpurwa Varanasi Uttar pradesh 221010
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7597364554 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhil Kapoor |
| Designation |
Assistant Professor, Medical oncology |
| Affiliation |
MPMMCC HBCH Varanasi |
| Address |
Room No 28, Department of Medical Oncology, Mahamana Pandit Madan Mohan Cancer Centre Sunderpur Varanasi
Room No. 6, Department of Medical Oncology, Old Loco Colony Shivpurwa Varanasi Uttar pradesh 221010
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7597364554 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavesh P Bandekar |
| Designation |
Scientific Officer |
| Affiliation |
Mahamana Pandit Madan Mohan Cancer Centre Sunderpur Varanasi |
| Address |
CRS Office, First Floor, Clinical Research Secretariat Department, Mahamana Pandit Madan Mohan Cancer Centre Sundarpur Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8779187963 |
| Fax |
|
| Email |
bhavesh.bandekar1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural grant
Mahamana Pandit Madan Mohan Cancer Centre Sundarpur Varanasi |
|
|
Primary Sponsor
|
| Name |
NO |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr BK Mishra |
Homi Bhabha Cancer Hospital |
OPD No. 6, Department of Medical Oncology, Old Loco Colony Shivpurwa Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
9415214254
bkmishra@mpmmcc.tmc.gov.in |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
OPD No. 28, Department of Medical Oncology, Sundar Bagiya Near Nariya Gate Sundarpur Varanasi
Varanasi
UTTAR PRADESH |
7597364554
kapoorakhil1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physician Choice Therapy |
INJ. methotrexate or
INJ. Docetaxel or
TAB. Capecitabine |
| Intervention |
Triple Metronomic |
TAB. Erlotinib 150mg OD
Capsule. Celecoxib 200mg BD
TAB. Methorexate 9mg/m2 weekly |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Head and neck cancers planned for palliative chemotherapy, post first line palliative chemotherapy failure
a.Patients who have failed within 6 months of curative treatment, where chemotherapy was a part will be considered.
2.Age : Any age ≥18 years
3.ECOG performance status ≤2
4.Histopathologically or FNAC (Fine needle aspiration cytology) proof of cancer.
5.Participants must have normal organ and marrow function as defined below:
a.Leukocytes ≥3,000/mcL
b.Platelets ≥100,000/mcL
c.Total bilirubin < 1.5 × institutional upper limit of normal
d.AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
e.Calculated Creatinine clearance > 30 ml/min
6.The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol.
7.Both men and women of all races and ethnic groups are eligible for this trial.
8.Willing and able to comply with all study requirements.
9.Ability to understand and the willingness to sign a written informed consent document |
|
| ExclusionCriteria |
| Details |
1.Participants who are currently receiving any other investigational agents.
2.Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of ondansetron. Patients in whom an initial evaluation QTc is prolonged but with medical interventions it is restored to normal are eligible for the study.
3.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
4.Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents within last 1 year, inflammatory bowel disease, known hyperkalemia ( CTCAE version 5 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. Patients who have uncontrolled hypertension or diabetes or other chronic medical condition at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility.
5.Pregnant women and breastfeeding women are excluded from this study because Chemotherapy agents have the potential for teratogenicity or abortifacient effects.
6.Patients who are able to receive immunotherapy (both financially and medically fit for the same), will be excluded from this study
All inclusion and exclusion criteria have to be satisfied for inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.QOL
2.Adverse event
3.Progression free survival |
1.At baseline one month two month and at six months post treatment completion
2. During the study treatment
3. From the date of randomization to date of progression |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Disease burden related to tobacco consumption and oral cancer is high in eastern region of Uttar Pradesh. Due to this, our study is planned to assess the effectiveness of different tobacco intervention methods for tobacco cessation as well as to find out potential pre malignant and malignant lesion and to provide appropriate health intervention at an earliest stage. Screening camp will be organized in coordination of Municipal office Varanasi city. Total 1200 municipal employees will be enrolled in the study. In each camp around 100-150 employees will be invited to attend the cancer awareness session and free oral cancer screening. After the cancer awareness session, Informed consent will be obtained to participate in this study. Those who are not willing to participate in the study, oral cancer screening will be offered. Participants with suspected oral lesion will be referred to HBCH/MPMMCC as per the MOU signed between HBCH/MPMMCC and Municipal Office Varanasi. Participants with current tobacco history will be randomly divided into groups for application of one of the behavioural intervention for tobacco cessation. Participant will be followed up at 1 month, 3 months, 6 months and 1 year to assess the tobacco cessation. If they have found using tobacco during follow up, the same intervention will be repeated, which was applied during recruitment of the participant in the study, except for those who had received group counselling initially. These participants will be provided individual counselling during follow up. Analysis of tobacco cessation rate will be done by assessing level of dependence using Fagerstrom scale. |