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

Phase 3

• Conditions: Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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