NCT05637567Not yet recruitingPhase 2
Perioperative Platelet Inhibition With Acetylsalicylic Acid in Patients With Resectable Tumors of the Pancreatic Head
Perioperative Platelet Inhibition With Acetylsalicylic Acid Targeting Intraoperative Tumor Cell Seeding in Patients With Resectable Tumors of the Pancreatic Head - a Randomized, Controlled Multicenter Study
Source: ClinicalTrials.gov · Last updated 13 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 24 Nov 2022
- Start date
- Apr 2024
- Primary completion date
- Sept 2028
- Lead sponsor
- German Cancer Research Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT05637567
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 170
- From Apr 2024 to the primary completion date, Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presumed necessity of arterial resection (other than gastroduodenal artery)
Other illness
- Metastatic disease (distant or peritoneal metastases or lymph node involvement considered distant metastasis (i.e., interaortocaval nodes))
- Neoadjuvant treatment for locally advanced disease
- 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
- 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
Lab values
- Preoperative use of anticoagulants / thrombolytics (e.g. warfarin, heparin), platelet aggregation inhibitors (e.g. ASA, ticlopidine, clopidogrel), chronic NSAID or metamizole use
- Advanced liver (INR \>1.5 or hepatic encephalopathy) or renal failure (stage IV or higher)
- Women of childbearing potential, except women who meet the following criteria:
- Post-menopausal (12 months natural amenorrhoea or six months amenorrhoea with serum follicle-stimulating hormone (FSH) \> 40 U/ml)
- Postoperative (six weeks after bilateral ovariectomy with or without hysterectomy)
- Regular and correct use of a contraceptive method with a failure rate \< 1% per year (e.g. implants, depot injections, oral contraceptives, intrauterine devices)
- Sexual abstinence
- Vasectomy of partner
Other
- 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
- Pregnant or breast-feeding women
- Indications that the patient is unlikely to comply with the protocol (e.g. unwillingness to cooperate)
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.