One drug compared to multidrug chemotherapy in elderly frail patients of pancreatic cancer

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of pancreas, unspecified,

• Registration Number: CTRI/2022/12/048500
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Pancreatic ductal adenocarcinomas (PDAC) are the most common tumors of the pancreasand frequently present in an advanced unresectable stage (80-85%). The rates of improvement in survivalin pancreatic cancers have been slow compared to the advances seen in other cancers. In metastaticpancreatic cancers, where median overall survival (mOS) is approximately 6-11 months only, palliativechemotherapy with gemcitabine had previously remained the cornerstone of treatment. However,improvements in mOS have been seen with combination regimens. The chemotherapy regimen which hasshown the maximum benefits in terms of outcomes is FOLFIRINOX. However, initial studies with thisregimen showed significant side effects. This has led clinicians and investigators to evaluate differentregimens which are more suitable to patients who are frail and elderly and may not tolerate theFOLFIRINOX regimen.It is unclear whether commonly used combination chemotherapy regimens containing more than one drugare better than using a single drug in terms of disease control and side-effect profile. This study willassess the disease control rate with different chemotherapy regimens (two-drug chemotherapy regimensversus single drug gemcitabine) in pancreatic cancer. All these regimes are part of standard chemotherapyoptions, 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 itwe 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 asper 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 thisarm are,1. Gemcitabine- Nab-Paclitaxel - Given as injections every 28 days on Day 1, Day 8 and Day 152. Gemcitabine-Cisplatin - Given as injections on Day 1 and Day 8 every 21 daysTreatment will be continued till unacceptable toxicity, death, or consent withdrawal.II. Arm B (Experimental) (weekly gemcitabine): In this arm the patient will receive only singleagent 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 anemergency 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 6months between the two therapies, Progression free survival (PFS) at 6 months, Response rates, Adverseevent rates/rates of side effects and Quality of life scales/measurements

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-23
• Study Start: 2022-12-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• . 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	42 months

Secondary Outcome Measures

Name	Time	Method
-Progression free survival (PFS)	-Disease control rates (DCR) and objective response rates (ORR)

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

sujay srinivas

Principal investigator

8447063693

sujay.0541@gmail.com