| CTRI Number |
CTRI/2023/07/055523 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Trastuzumab plus chemotherapy vs Chemotherapy alone in first-line HER2 positive advanced biliary tract cancer patients - a randomized non-blinded two-arm Phase III prospective clinical trial. |
|
Scientific Title of Study
|
Trastuzumab plus chemotherapy vs Chemotherapy alone in first-line HER2 positive advanced biliary tract cancer patients - a randomized non-blinded two-arm Phase III prospective clinical trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF VIKAS OSTWAL |
| Designation |
Professor & Medical oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1102,Departmeent of medical oncology, Homi bhabha block Tata Memorial Hospital
E. BORGES ROAD, PAREL, MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02269537300 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIKAS OSTWAL |
| Designation |
Professor & Medical oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
E. BORGES ROAD, PAREL, MUMBAI
E. BORGES ROAD, PAREL, MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02269537300 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF VIKAS OSTWAL |
| Designation |
Professor & Medical oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
E. BORGES ROAD, PAREL, MUMBAI
E. BORGES ROAD, PAREL, MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02269537300 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| We will request for Drug support from pharma company and we will request for intramural and extramural grant |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
dr.E borges road pare, mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Kumar |
Homi Bhabha Cancer Hospital and Research Centre |
Department of Medical Oncology, Homi Bhabha Cancer and Research Centre, Uma Nagar, Rasulpur Saidpur Bazid, Muzaffarpur, Bihar - 842004
Muzaffarpur
BIHAR |
9264493969
-
gaurav_crj@rediffmail.com |
| Dr Alok Goel |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center) |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center), Medicity, Plot no.1, New Chandigarh, Punjab 140901
Chandigarh
CHANDIGARH |
9899701286
alokdrgoel@gmail.com |
| Dr Bal Krishna Mishra |
Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMC) and Homi Bhabha Cancer Hospital (HBCH) |
MPMMCC and HBCH, Varanasi, Sundar Bagiya,Near Nariya Gate, Banaras Hindu University Campus,Varanasi 221005,Uttar Pradesh
Varanasi
UTTAR PRADESH |
9415214254
bkmmishra@hotmail.com |
| Dr Vikas Ostwal |
Tata Memorial Hospital |
Department of Medical Oncology (GI),1102,11th floor,Tata Memorial Hospital,Dr Ernest Borges Road,Parel,Mumbai 400012,Maharashtra
Mumbai
MAHARASHTRA |
9702288801
dr.vikas.ostwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Tata Memorial Hospital |
Approved |
| Institutional Ethics committee |
Approved |
| Institutional Ethics Committee (IEC) |
Approved |
| Institutional Ethics Committee HBCH And RC Mullanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C249||Malignant neoplasm of biliary tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard chemotherapy alone
Gemcitabine plus cisplatin OR Gemcitabine plus paclitaxel |
Gemcitabine 1000mg/m2 IV over 30 mins Plus Cisplatin 25 mg/m2 IV over 60 minutes, D1 and D8 q 21 days
OR
Gemcitabine 800mg/m2 IV over 30 mins, Plus Cisplatin 25 mg/m2 IV over 60 minutes, Plus Nab-paclitaxel 100 mg/m2 over 30 minutes, D1 and D8
Start of next cycle on D 22
|
| Intervention |
trastuzumab plus gemitabine plus cisplatine OR gemcitabine and nabpaclitaxel |
Gemcitabine 1000mg/m2 IV over 30 mins Plus Cisplatin 25 mg/m2 IV over 60 minutes,D1 and D8
Plus Trastuzumab 8 mg/kg IV over 90-minutes followed by subsequent doses of 6 mg/kg IV over 30–90 minutes, D1
Start of next cycle on D 22
OR
Gemcitabine 800mg/m2 IV over 30 mins, Plus Cisplatin 25 mg/m2 IV over 60 minutes, Plus Nab-paclitaxel 100mg/m2 over 30 minutes, D1 and D8
Plus Trastuzumab 8 mg/kg IV over 90-minutes followed by subsequent doses of 6 mg/kg IV over 30–90 minutes, D1
Start of next cycle on D 22
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications
2.HER2 positive (by IHC or FISH) unresectable or metastatic Biliary tract cancers.
3.Age more than or equal to 18 years, ECOG performance status 0 to 2.
4.Patient does not have any contraindications to receive chemotherapy or trastuzumab.
5.Adequate hematological, hepatic, and renal function parameters
6.Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) more than or equal to 50% or above the lower limit of normal. ECG with no clinically relevant abnormalities.
7.Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
8.Subjects must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures.
9.Subjects who have received adjuvant chemotherapy will be considered eligible provided that therapy is completed more than 12 months before study enrollment. Patients who have received radiation therapy and surgery will also be eligible provided the interventions have been completed 3 weeks, before enrolment in the study.
10.Negative serum pregnancy test (if applicable) and willing for adequate contraception.
11.At least one measurable disease according to RECIST criteria.
12.A life expectancy of at least 12 weeks.
|
|
| ExclusionCriteria |
| Details |
1.Distal cholangiocarcinoma
2.Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab-paclitaxel, or trastuzumab.
3.Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III to IV.
4.Clinically significant valvular defect.
5.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
6.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
7.Baseline neuropathy greater than NCI Grade I.
8.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
9.Received prior chemotherapy within 1 year.
10.Any active ILD or history of lung illness requiring bronchodilator drugs.
11.Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the difference in progression free survival at 6 months between Trastuzumab chemotherapy combination & chemotherapy alone |
To evaluate the difference in progression free survival at 6 months between Trastuzumab chemotherapy combination & chemotherapy alone |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the difference in Overall Survival between the Trastuzumab chemotherapy combination & chemotherapy alone.
To evaluate the difference in overall response rates between Trastuzumab chemotherapy combination and chemotherapy alone.
|
To evaluate the difference in Overall Survival between the Trastuzumab chemotherapy combination & chemotherapy alone.
To evaluate the difference in overall response rates between Trastuzumab chemotherapy combination and chemotherapy alone.
|
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
02/08/2023 |
| 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="6"
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
|
NIL |