| CTRI Number |
CTRI/2022/10/046520 [Registered on: 17/10/2022] Trial Registered Prospectively |
| Last Modified On: |
22/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A superiority study of comparing oral metronomic therapy with Paclitaxel and Carboplatin Vs. Chemotherapy alone in patients with advanced unresectable Head and Neck cancer patients. |
|
Scientific Title of Study
|
A phase III, randomized, open label study to establish the superiority of metronomic therapy used in addition to the chemotherapy regimen (Paclitaxel and Carboplatin) over the chemotherapy alone for the treatment of advanced unresectable head and neck cancer. |
| Trial Acronym |
Pacli Carbo OMCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC Project No. 11000587 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Kapoor |
| Designation |
Associate Professor, Department of Medical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
OPD No.28, Ground floor, DNT Block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC), Sundarpur,
Varanasi 221005
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar bagiya, Banaras Hindu University Campus, Sundarpur, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9950482121 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Bhavesh P Bandekar |
| Designation |
Scientific Officer, Clinical Research Secretariat |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar bagiya, Banaras Hindu University Campus, Sundarpur, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08779187963 |
| Fax |
|
| Email |
bhavesh.bandekar1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Bhavesh P Bandekar |
| Designation |
Scientific Officer, Clinical Research Secretariat |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar bagiya, Banaras Hindu University Campus, Sundarpur, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08779187963 |
| Fax |
|
| Email |
bhavesh.bandekar1988@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cancer Research Secretariat, Tata emorial Centre, 3rd Floor, Main Building, Dr. E Borges Road, Parel 400012 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre TRAC |
| Address |
Dr. E. Borges Road, Parel, Mumbai 4000012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC), Unit of Tata Memorial Centre, Mumbai |
Department of Medical Oncology, OPD No. 28, DNT Block, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi (U.P.) 221005 India
Varanasi
UTTAR PRADESH |
9950482121
kapoorakhil1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MPMMCC & HBCH, Varanasi |
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 |
| Intervention |
Oral Metronomic therapy used in addition with Paclitaxel and carboplatin chemotherapy regimen |
OMCT will be administered with tablet erlotinib 150 mg (fixed dose) PO OD daily, capsule celecoxib 200 mg
(fixed dose) PO BD daily and oral weekly methotrexate 9 mg/m2.The participants in this arm will receive palliative chemotherapy with paclitaxel carboplatin plus
Triple OMCT. In each cycle the participants will have 21 days gap. |
| Comparator Agent |
Physician choice therapy |
Patients on arm B will receive physician choice therapy with one taxane and with one platin which
can be Docetaxel (75 mg/m2) on day 1 in 3 weekly cycles, paclitaxel (175 mg/m2) on day 1 in 3 weekly
cycles, injection methotrexate (40 mg/m2) weekly (D1, 8 and 15) in 3 weekly cycles, Capecitabine 1250mg/m2 BD, D1-14) 3 weekly or any other suitable choice as per institutional standard |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Advanced head and neck squamous cell cancers planned for palliative chemotherapy, post first line
palliative chemotherapy failure
2. Patients who have failed within 6 months of curative treatment, where chemotherapy was a part will be
considered.
3. Age : Any age ≥18 years
4. ECOG performance status ≤2
5. Histopathologically or FNAC (Fine needle aspiration cytology) proof of cancer (squamous cell carcinoma).
6. 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 hyperkalaemia ( 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
conditions 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
7. All inclusion and exclusion criteria have to be satisfied for inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall Survival |
OS will be defined in months between the date of randomization to date of death. Patients alive at their
last follow ups would be censored |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Progression Free Survival
QOL
Adverse Events |
From the date of randomization to date of progression or death.Adverse event will be captured throughout the study till death QOL score at baseline 3 cycle 9 weeks plus or minus 15 days and 6 months futures 3 monthly interval |
|
|
Target Sample Size
|
Total Sample Size="238"
Sample Size from India="238"
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)
|
18/10/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable since Study not yet recruiting |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Head and neck cancer is one of the commonest malignancy seen in India. Unfortunately 85% of patients are seen in locally advanced stage. Hence majority of the patients fail. Palliative chemotherapy is one of the main treatment options in this situation. However, except in first line situation there is no standard medical treatment, especially when the cost of immunotherapy and targeted medications like cetuximab make this option unfeasible for majority of the patients. Inspite of the cost, the outcomes provided by these medications are at best modest. The propsosed study is an Investigator-initiated, Phase III, randomised open label, controlled trial to see whether oral metronomic therapy given along with palliative chemotherapy (Paclitaxel + Carboplatin) to the patient diagnosed with advanced unresectable head and neck cancer increases overall survival compared to patients getting chemotherapy alone (however not the same chemotherapy agents). This is a superiority trial in which PI comparing the physicians choice treatment with oral matronomic chemotherapy erlotinib 150 mg fixed dose celexoxib 200 ng fixed dose oral methotrexate 9 mg/m2 relative chemotherapy of paclitaxel and carboplatin Stratified randomisation site of the tumor and ECOG PS. Patient is going to bear the cost of complication arising from the experimental treatment. This is beneficial to local community as the burden of head and neck cancers is very high in the area with most patients cannot access immunotherapy/ new drugs. If ths regimen demonstrates a survival benefit it will be an alternative that most patients will afford. This study involves the comparison between oral metronomic therapy (oral drugs of chemotherapy) given with paclitaxel +carboplatin versus chemotherapy alone. Arms of the study Arm A: The participants in this arm will receive palliative chemotherapy with paclitaxel carboplatin plus triple OMCT. In each cycle the participants will have 21 days gap. OMCT will be administered with tablet erlotinib 150 mg (fixed dose) PO OD daily, capsule celecoxib 200 mg (fixed dose) PO BD daily and oral weekly methotrexate 9 mg/m2.
Arm B: Patients on arm B will receive physician choice therapy with one taxane and with one platin which can be Docetaxel (75 mg/m2) on day 1 in 3 weekly cycles, paclitaxel (175 mg/m2) on day 1 in 3 weekly cycles, injection methotrexate (40 mg/m2) weekly (D1, 8 and 15) in 3 weekly cycles, Capecitabine (1250mg/m2 BD, D1-14) 3 weekly or any other suitable choice as per institutional standard. The outcomes will be compared in terms of survival and also, the toxicities will be monitored. |