Clinical trial NCT05178628: The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer
Official title: The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer: The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Thromboembolism
Keywords: Thromboprophylaxis
Advanced Pancreatic Cancer
Lead sponsor: Institute of Molecular Medicine and Biomedical Research
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, multicenter, open-label, blinded-endpoint Phase III clinical trial
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized, multicenter, open-label, blinded-endpoint Phase III clinical trial to investigate the impact of thromboprophylaxis using innohep, beyond anticoagulation in the improvement of the clinical outcomes in active pancreatic cancer patients receiving systemic anti-neoplasmatic treatment. The number of patients that will be enrolled is 450. The enrollment period is 24 months and the follow up period is 10 months.

Detailed description: Pancreatic cancer (PC) has the worst prognosis of any malignancy. Venous thromboembolism (VTE) occurs in 1:5 PC patients and is associated with significantly reduced progression-free survival (PFS). Phase III randomised controlled trials concluded that targeted thromboprophylaxis with low molecular weight heparins (LMWH) resulted in an 82% reduction in the relative risk of VTE without increasing major bleeding events, and that 11 patients were needed to be treated to prevent one VTE during chemotherapy. The benefits observed in the many of reported studies could not be accounted for by VTE prevention alone. Numerous experimental studies have demonstrated the antitumour, anti-metastatic and chemo-resistance reversal effect of LMWH.

The vast majority of the so far published evidence assessing the efficacy and safety of VTE prevention in ambulatory cancer patients is based on mixed patient populations with various types of cancers. Thus, current studies do not allow to estimate the real effect of long-term prophylaxis on clinical outcomes in selected homogeneous high-thrombotic risk patients.

An approach more specific to PC and restricted to advanced or metastatic patients is a modern and attractive strategy to assess the benefit of thromboprophylaxis in VTE prevention and beyond anticoagulation.

The objective of the imPaCT-PRO trial is to investigate the impact of thromboprophylaxis beyond anticoagulation in the improvement of the clinical outcomes in active PC patients receiving systemic anti-neoplasmatic treatment.

Eligibility criteria: Inclusion Criteria:

1. Advanced or metastatic PC (confirmed by the recommended histological and imaging methods).
2. Age ≥ 18 years.
3. Planning to start 1st line chemotherapy with NabG.
4. Eastern Cooperative Group (ECOG) 0-2.
5. Life expectancy \>6 months.
6. Written informed consent.

Exclusion Criteria:

1. Subjects with contraindication to receive anticoagulant:

   1. Any hypersensitivity to anticoagulant or excipients.
   2. History of heparin-induced thrombocytopenia type II (HIT II).
   3. Active major bleeding or pre-diathesis for major bleeding
   4. Septic endocarditis.
2. Creatinine clearance \<20 mL/min according to Cockcroft-Gault formula.
3. Platelet count \< 50 G/L at inclusion.
4. Hepatic dysfunction defined as at least one of the following: AST and/or ALT \> 5 x ULN, bilirubin \> 2 x ULN.
5. Recent (\< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery.
6. Recent (\< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke.
7. Patients on chronic anticoagulation or on dual anti-platelet treatment.
8. Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.
9. Severe concomitant disease that as per investigator's judgement is not compatible with participation in the study.

Primary outcomes:
measure: PFS of patients
timeFrame: 12 months
measure: The number of VTE events during the trial
timeFrame: 12 months
Secondary outcomes:
measure: % of patients experiencing at least one major bleeding event
timeFrame: Through study completion, an average of 2 years
measure: % of patients experiencing any bleeding event
timeFrame: Through study completion, an average of 2 years
measure: VTE events
timeFrame: Through study completion, an average of 2 years
measure: Patients with complete or partial response
timeFrame: Through study completion, an average of 2 years
measure: Change from baseline in QoL
timeFrame: at 4 and 10 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Institute of Molecular Medicine and Biomedical Research
state: Attiki
city: Athens
country: Greece
facility: Eygenideio Hospital, Oncology Department
state: Attiki
Study officials:
References: