Perioperative Platelet Inhibition With Acetylsalicylic Acid in Patients With Resectable Tumors of the Pancreatic Head

NCT05637567 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DKFZ-2022-006
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, controlled clinical trial compares the perioperative treatment with acetylsalicylic acid (aspirin) in patients with cancer of the pancreatic head. The main question it aims to answer is: Do patients treated perioperatively with aspirin develop less metastasis after curative resection of pancreatic head tumors? Participants will be asked to :

• take a daily aspirin tablet starting 1-4 weeks before surgery until 6 months after surgery
• participate in regular follow-up visits.

Conditions

Pancreatic Cancer Resectable

Keywords

pancreatic cancer; pancreatic head cancer; acetylsalicylic acid; aspirin; pancreatic head resection; liver metastases; distant metastases; circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• Hematogenous metastases-free survival

  The primary efficacy endpoint of the study is hematogenous metastases-free survival (HMFS), which is defined as the time from the day of surgery to the date of diagnosis of hematogenous distant metastases (e.g., hepatic or pulmonary metastases) or date of death from any cause, whichever comes first. Peritoneal metastases (peritoneal carcinomatosis) are not regarded hematogenous metastases. The HMFS status is evaluated at regular follow-up examinations for 36 months postoperatively and further recorded during clinical follow-up visits until the end of the trial.

  24 months

Secondary Outcomes (9)

• Overall survival

  24 months

• Cancer-specific survival

  24 months

• Disease-free survival

  24 months

• Intraoperative blood loss

  During surgery

• Duration of surgery

  During surgery

Study Arms (2)

Treatment Arm

EXPERIMENTAL

100 mg acetylsalicylic acid per os once daily, starting 1-4 weeks before surgery until 6 months after surgery

Drug: Acetylsalicylic acid

Control Arm

PLACEBO COMPARATOR

Identically looking placebo pill, starting 1-4 weeks before surgery until 6 months after surgery

Drug: Placebo

Interventions

Acetylsalicylic acid DRUG

100 mg per os once daily

Treatment Arm

Placebo DRUG

Placebo pill per os once daily

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication: Patients with (histologically confirmed or clinically suspected) surgically resectable, non-metastatic ductal adenocarcinoma of the pancreatic head
• Patients planned for pylorus-preserving partial pancreaticoduodenectomy (PPPD / "ppWhipple" / Traverso-Longmire procedure) (conventional or minimally invasive)
• Male and female patients aged 18 to 80 years
• Written informed consent of the participating person
• ECOG≤2

You may not qualify if:

• Metastatic disease (distant or peritoneal metastases or lymph node involvement considered distant metastasis (i.e., interaortocaval nodes))
• Preoperative use of anticoagulants / thrombolytics (e.g. warfarin, heparin), platelet aggregation inhibitors (e.g. ASA, ticlopidine, clopidogrel), chronic NSAID or metamizole use
• Neoadjuvant treatment for locally advanced disease
• Presumed necessity of arterial resection (other than gastroduodenal artery)
• Advanced liver (INR \>1.5 or hepatic encephalopathy) or renal failure (stage IV or higher)
• Advanced heart disease (NYHA class ≥ 3)
• Known hypersensitivity to ASA or to drugs with a similar chemical structure
• History of asthma attacks triggered by salicylates or substances with similar effects
• Haemorrhagic diathesis, blood coagulation disorders such as haemophilia or thrombocytopenia
• Thrombocytosis \> 450,000 / μL
• Methotrexate at a dosage of 15 mg or more per week
• Participation in competing trials affecting the effects of the investigational medicinal product (IMP) or outcome measures
• Addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences
• Pregnant or breast-feeding women
• Women of childbearing potential, except women who meet the following criteria:

Sponsors & Collaborators

• German Cancer Research Center: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplastic Cells, Circulating

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sebastian Schoelch, MD

  German Cancer Research Center

  STUDY CHAIR

Central Study Contacts

Sebastian Schoelch, MD

CONTACT

+49621383; s.schoelch@dkfz.de

Johanna Betzler, MD

CONTACT

+49621383; johanna.betzler@dkfz.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 5, 2022
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share