| CTRI Number |
CTRI/2022/12/048500 [Registered on: 26/12/2022] Trial Registered Prospectively |
| Last Modified On: |
23/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
One drug compared to multidrug chemotherapy in elderly frail patients of pancreatic cancer |
|
Scientific Title of Study
|
Physician choice Multi-agent chemotherapy versus Gemcitabine monotherapy for advanced
Pancreatic adenocarcinomas in frail or Elderly patients - a randomized phase III clinical trial
|
| Trial Acronym |
MaGPiE study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujay Srinivas |
| Designation |
Associate Professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of medical oncology tata memorial hospital 11th floor homibhabha room no 1102 dr ernest borges marg parel mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
sujay.0541@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujay Srinivas |
| Designation |
Associate Professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of medical oncology tata memorial hospital 11th floor homibhabha room no 1102 dr ernest borges marg parel mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
sujay.0541@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujay Srinivas |
| Designation |
Associate Professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of medical oncology tata memorial hospital 11th floor homibhabha room no 1102 dr ernest borges marg parel mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
sujay.0541@gmail.com |
|
|
Source of Monetary or Material Support
|
| intramural tata memorial hospital dr ernest borges marg parel mumbai and extramural |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
dr ernest borges marg parel mumbai 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 |
| sujay srinivas |
Tata Memorial Hospital |
Department of medical oncology 11th floor room no 1102 homibhabha building dr ernest borges marg parel mumbai
Mumbai
MAHARASHTRA |
8447063693
sujay.0541@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: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multiagent chemotherapy |
Gemcitabine nab Paclitaxel
Gemcitabine 1000 mg per m2 IV plus Nab paclitaxel 125 mg or m2 IVD1, D 8 and D15 q 28 days1 cycle equal to 28 days Start of next IV cycle on D 29Treating physicians can use a D1, D15 q 28 day schedule as per their treatment preference
- Gemcitabine Cisplatin Gemcitabine 1000 mg per m2 IV plus Cisplatin 25 mg per m2 IV D1 and D8 q 21 days 1 cycle 21 days Start of next IV cycle on D 22
|
| Comparator Agent |
weekly gemcitabine |
The treatment in this arm will consist of Gemcitabine 1000 mg/m2 IV D1, D8, D15 q 28 days 1 cycle equal to 28 days Start of next IV cycle on D 29 The patient will be on supportive care and reviewed periodically every 2 months +or - 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
. Histologically confirmed locally advanced unresectable or metastatic adenocarcinoma of the
pancreas or ampulla, either by FNAC or biopsy of the primary site or metastatic site, with the
following specifications
ECOG PS 2 and age more than equal to 18 years OR
- Age more than or equal to 70 years with G8 screening score < 14 and CARG score of intermediate or high
risk.
Adequate haematological, hepatic and renal function parameters.
- Haematological- Hb> 80 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L.
- Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT ≤ 5 x ULN,
alkaline phosphatase ≤ 6 x upper limit normal (ULN), S. albumin ≥ 2.5 g/L,
-Renal function-estimated creatinine clearance >40 ml/min according to the CockcroftGault formula.
- Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography
- Women of childbearing age should have a negative urine pregnancy test or serum β-hcg at
the time of randomization and should be willing to use adequate contraception during the
treatment phase of the trial.
-Willing to provide written informed consent form.
|
|
| ExclusionCriteria |
| Details |
Patients who meet any of the below criteria will be excluded from the study:
-Patients with borderline resectable pancreatic cancer, resectable pancreatic cancers, orresectable ampullary cancers
-Patients with known hypersensitivity or contraindications against gemcitabine, nabPaclitaxel, 5-FU,Capecitabine, Cisplatin or Oxaliplatin.
-Patients with clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, significant valvular defect.
-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
-Patients with severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
-Patients with baseline neuropathy more NCI Grade II
-Patients with unhealed surgical wounds
-Patients with uncontrolled co morbidities like diabetes (random blood sugar more than 200) and hypertension more than 140/90 mm hg) which are common at this age.
-On treatment participation in another clinical study in the period 30 days before inclusion and during the study
- Pregnant or breastfeeding women, or planning to become pregnant within 6 months after the end of treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival |
42 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Progression free survival (PFS)
-Disease control rates (DCR) and objective response rates (ORR)
-Quality of life (QOL) |
42 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
30/12/2022 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pancreatic ductal adenocarcinomas (PDAC) are the most common tumors of the pancreas
and frequently present in an advanced unresectable stage (80-85%). The rates of improvement in survival
in pancreatic cancers have been slow compared to the advances seen in other cancers. In metastatic
pancreatic cancers, where median overall survival (mOS) is approximately 6-11 months only, palliative
chemotherapy with gemcitabine had previously remained the cornerstone of treatment. However,
improvements in mOS have been seen with combination regimens. The chemotherapy regimen which has
shown the maximum benefits in terms of outcomes is FOLFIRINOX. However, initial studies with this
regimen showed significant side effects. This has led clinicians and investigators to evaluate different
regimens which are more suitable to patients who are frail and elderly and may not tolerate the
FOLFIRINOX regimen.
It is unclear whether commonly used combination chemotherapy regimens containing more than one drug
are better than using a single drug in terms of disease control and side-effect profile. This study will
assess the disease control rate with different chemotherapy regimens (two-drug chemotherapy regimens
versus single drug gemcitabine) in pancreatic cancer. All these regimes are part of standard chemotherapy
options, and any of these can be used to treat this type of cancer.
G8 tool is a well-studied tool which helps in comprehensively evaluating elderly patients and by using it
we can identify elderly patients at higher risk of chemotherapy side-effects.
The purpose of this study is to find out whether a two-drug chemotherapy regimen is better than singledrug gemcitabine in terms of disease control, in pancreatic cancer in elderly and frail patients selected as
per their performance status and G8 scores. reatment Overview: Post enrolment, patient will be randomized into one of two treatment arms:-
I. Arm A (Physician choice multiagent chemotherapy): The treatment regimens allowed in this
arm are,
1. Gemcitabine- Nab-Paclitaxel - Given as injections every 28 days on Day 1, Day 8 and Day 15
2. Gemcitabine-Cisplatin - Given as injections on Day 1 and Day 8 every 21 days
Treatment will be continued till unacceptable toxicity, death, or consent withdrawal.
II. Arm B (Experimental) (weekly gemcitabine): In this arm the patient will receive only single
agent chemotherapy – Gemcitabine given as injection on Day 1, Day 8 and Day 15 every 28 days.
Patient will be on supportive care and reviewed periodically every 2-3 months as per study or on an
emergency basis in case of symptomatic disease worsening.
Treatment will be continued till unacceptable toxicity, death, or consent withdrawal.
The expected outcomes are to evaluate the difference in survival called as overall survival (OS) at 6
months between the two therapies, Progression free survival (PFS) at 6 months, Response rates, Adverse
event rates/rates of side effects and Quality of life scales/measurements |