| CTRI Number |
CTRI/2025/02/080952 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Randomized blinded phase 3 trial of Evaluation of the effectiveness and tolerability of Olanzapine, Aprepitant,IV Dexamethasone and Palanosetron as compared to Olanzapine, Aprepitant,Palanosetron and palcebo in patients receiving chemotherapy that causes moderate nausea or vomitting or both |
|
Scientific Title of Study
|
A randomized, placebo controlled, phase 3, triple blinded study to investigate the efficacy and tolerability of Olanzapine, Aprepitant,IV Dexamethasone and Palanosetron versus Olanzapine, Aprepitant,Palanosetron and palcebo in patients receiving moderately emetogenic chemotherapeutic (MEC) regimens (OMEC2) |
| Trial Acronym |
OMEC 2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikas Ostwal |
| Designation |
Professor and Consultant Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1102,Department of Medical Oncology GI, 11th Floor,
Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road,
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Ostwal |
| Designation |
Professor and Consultant Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1102,Department of Medical Oncology GI, 11th Floor,
Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road,
Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Ostwal |
| Designation |
Professor and Consultant Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1102,Department of Medical Oncology GI, 11th Floor,
Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road,
Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| We will request for Drug support and extramural grant from pharma companies and we will request for intramural fund from Tata Memorial Hospital, Dr Ernest Borges Road, Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai
Maharashtra India 400012 |
| 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 Vikas Ostwal |
Tata Memorial Hospital |
OPD 319, Dept of GI Medical Oncology, 3rd floor,Homi Bhabha Building, Tata Memorial Hospital, Dr Ernest Borges Road,Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9702288801
dr.vikas.ostwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Olanzapine, Aprepitant,IV Dexamethasone and Palanosetron |
In control arm, the patients will receive 4 drug antiemetic regimen Olanzapine, Aprepitant,IV Dexamethasone and Palanosetron
Control arm (4 drug antiemetic regimen)
Day 1
60 mins before chemotherapy,
Capsule Aprepitant 125 mg PO plus
Palonosetron 0.25mg IV plus
Dexamethasone 12 mg IV
Tablet Olanzapine 10 mg PO at night prior to sleep (oral and written instructions will be given to patient)
Day 2 and Day 3
Capsule aprepitant 80 mg PO plus
Tablet Olanzapine 10mg PO at night prior to sleep
Oral and written Instructions will be given to patient regarding oral intake of capsule Aprepitant and tablet
olanzapine for day 2 and day 3 |
| Comparator Agent |
Olanzapine, Aprepitant,IV, Palanosetron plus placebo |
In experimental arm, the patients will receive 3 drug antiemetic regimen Olanzapine, Aprepitant,IV, Palanosetron plus placebo
Experimental arm (3 drug antiemetic regimen + placebo)
Day 1
60 mins before chemotherapy,
Capsule aprepitant 125 mg PO plus
Palonosetron 0.25mg IV plus
Inj Placebo 12 mg IV OD
Tablet Olanzapine 10 mg PO at night prior to sleep (oral and written instructions will be given to patient)
Day 2 and Day 3
Capsule aprepitant 80 mg PO plus
Tablet Olanzapine 10mg PO at night prior to sleep
Oral and written Instructions will be given to patient regarding oral intake of capsule Aprepitant and tablet
olanzapine for day 2 and day 3. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients has a confirmed diagnosis of one of the cancers mentioned below
i.Esophageal,gastro-esophageal and gastric cancers
ii.Non-small cell cancers
iii.Pancreatic cancers
iv.Gallbladder cancers
v.Small-bowel adenocarcinomas
vi.Penile cancers
vii.Urinary bladder transitional cell carcinomas
viii.Colorectal cancer
ix.Gynecological cancers
and
is receiving one of the mentioned chemotherapy protocols as below.
i.Modified FOLFIRINOX(every 2 weeks)
ii.CAPIRI(every 3 weeks)
iii.CAPOX(every 3 weeks)
iv.Modified FOLFOX
v.Pemetrexed plus Carboplatin(every 3 weeks)
vi.GEMOX(Gemcitabine + Oxaliplatin)(every 2 weeks)
vii.Gemcitabine plus carboplatin(3 Weekly)
viii.Single Agent carboplatin (auc 5-7) 3 weekly regime
ix.mDOF 2 weekly
2.The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
3.The patient is aged more than 18 years.
4.Patients should be chemotherapy naïve.
5.The patient has a WHO Performance Status of ≤ 1.
6.Hematologic and metabolic status must be adequate for receiving planned chemotherapy, and meet the following criteria:
Total neutrophils more than 1500 per mm3
Platelets more than 100,000 per mm3
Bilirubin less than 1.5 times ULN(Upper Limits of Normal)
Aspartate aminotransferase (AST)and or alanine aminotransferase (ALT) less than 3 into ULN GFR more than 50 ml per min
7.The patient or the attendant is able to read,understand,and complete questionnaires and daily components of the Patient Diary for each study cycle.
8.For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) or blood hCG results must be negative at screening.
9.Has a normal baseline ECG with no QTc prolongation |
|
| ExclusionCriteria |
| Details |
1.The patient and or attendant are unable to read, understand,and complete the forms required for the study.
2.The patient is pregnant or lactating.
3.The patient has experienced emesis (i.e.vomiting and/or retching) or clinically significant nausea (defined as nausea graded as moderate or severe) in the 24 hours preceding the first dose of study medication.
4.The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure,severe cognitive impairment, known central nervous system disease (e.g. brain metastases or a seizure disorder).
5.Hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the patient.
6.The patient has a known hypersensitivity or contraindication to palonosetron, another 5-HT3 receptor antagonist, dexamethasone, aprepitant or olanzapine.
7.The patient has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medications.Opiate drugs for cancer pain will be permitted if the patient has been on a stable dose and has not experienced emesis or clinically significant nausea from the narcotics in the 24 hours preceding the first dose of study medication.
8.The patient has taken or received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drugs. This is inclusive of, but not limited to 5 HT3 antagonists, metoclopramide, benzodiazepines, phenothiazines, haloperidol, oral or intravenous steroids, antihistamines, domperidone, olanzapine, antipsychotics.
9.Patient on antipsychotics or being planned to receive any of the antiphychotics, amifostine in last 3 months.
10.Patient has received concurrent abdominal radiotherapy in last 3 months or being planned to receive the same.
11.Patient is receiving or will likely to receive concurrent use of quinolone antibiotic therapy.
12.Patient with the history of chronic alcoholism.
13.Patient with cardiac arrhythmia, uncontrolled/ controlled heart failure, or acute coronary event or uncontrolled diabetes mellitus within the previous 6 months.
14.Has taken drugs which may influence medications used in the study, e.g. CYP inducers or inhibitors. This will have to be evaluated for and decision taken by PI. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to compare an antiemetic regimen consisting of aprepitant, palonosetron, dexamethasone and olanzapine (standard arm) and a regimen consisting of aprepitant, palonosetron, olanzapine, and placebo (experimental arm) with respect to complete response (CR) and the proportion of subjects with no vomiting,no significant nausea (scored as less than 5 on a scale of 1-100) and no use of rescue medications during pre-specified MEC protocols during the 1st cycle of chemotherapy |
during the 1st cycle of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the dexamethasone free regimen to the control arm with respect to no emesis rates(the proportion of subjects with no vomiting, & no use of rescue medications) during pre-specified high MEC protocols for 1 & 3 cycles of chemotherapy
2.To compare the dexamethasone free regimen to the control arm with respect to proportion of patients with no significant nausea(less than 5 on a score of 1-100)during pre-specified high MEC protocols for 1 to 3 cycles of chemotherapy
3.To compare the the dexamethasone free regimen to the control arm with respect to CR rates during pre-specified high MEC protocols for the second & third cycles of chemotherapy
4.To compare quality of life using FLIE questionnaire
5.To compare tolerance & side effects with both regimens
6.To assess the chemotherapy drug induced reactions & compare them in dexamethasone vs placebo arms. |
For 1 to 3 cycles of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="834"
Sample Size from India="834"
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)
|
25/02/2025 |
| 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="4"
Months="0"
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
|
Chemotherapy often causes nausea and vomiting, which can be
very upsetting. This affects how patients feel and their ability to stick to
treatment. Minimizing these side effects improves patients’ lives. The main
goal of the study is to compare two anti-nausea treatment plans. One includes
aprepitant, palonosetron, dexamethasone, and olanzapine (standard), while the
other substitutes dexamethasone with a placebo (experimental). We’re looking at
how well each plan prevents vomiting, reduces nausea, and avoids extra medication during specific
chemotherapy cycles. All patients screened will be listed on the
"Screening list." Those meeting inclusion criteria and no exclusion
criteria will be added to the "Inclusion list" and
"Identification list" with a unique ID for the study. We need 834
patients for the study, grouped in blocks of four and randomly assigned one of the two treatment plan.Before starting chemotherapy on Day 1, patients will
receive medication either with dexamethasone (Control arm) or placebo
(Experimental arm) alongside other drugs. Olanzapine tablets will be taken the
night before. On Days 2-3, patients will self-administer medications according
to the given schedule. Patients will be contacted telephonically by the study
team to report medication intake, vomiting episodes, and nausea levels.
Mid-cycle evaluation (Day 7-10) post chemotherapy will include assessing medication
intake, nausea/vomiting episodes, and completing questionnaires. End-of-cycle
assessments will be done, and follow-up visits are required for study
completion. |