Clinical trial · Interventional
Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer
Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment prematurely stopped due to a lack of eligible patients.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer. PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy at the investigator's discretion | Drug | — | UNRESOLVED |
| daltéparine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- chemotherapy at investigator's discretion
- interventionNames
- Drug: Chemotherapy at the investigator's discretion
- type
- EXPERIMENTAL
- label
- dalteparin
- description
- dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.
- interventionNames
- Drug: daltéparine
- Drug: Chemotherapy at the investigator's discretion
Primary outcomes (1)
- measure
- Thromboembolic events
- timeFrame
- during study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * Metastatic disease * Not amenable to treatment * No localized or locally advanced disease * Measurable disease (metastatic or primary tumor) defined as ≥ 2 cm by CT scan or ≥ 1 cm by spiral CT scan or MRI * No progressive thrombo-embolic disease * No adenocarcinoma of the biliary tract or ampulla of Vater * No known CNS metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy \> 12 weeks * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Alkaline phosphatase \< 5 times normal * Bilirubin \< 1.5 times normal * Creatinine \< 1.5 times normal * Creatinine clearance \< 30 mL/min * Pain controlled or stabilized via analgesic therapy * Affiliation with social security system * Not pregnant or nursing * No controlled or uncontrolled jaundice * No contraindication to study drugs * No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months * No serious cardiac and/or respiratory disease * No other cancer in the past 5 years except the following cancers, provided they have been completely resected: * Skin cancer * Localized melanoma * Carcinoma in situ of the cervix * No history of thrombophilia * No history of heparin-induced thrombocytopenia * No uncontrolled or persistent hypercalcemia * No psychological, familial, social, and/or geographical condition that precludes participation in the study PRIOR CONCURRENT THERAPY: * No prior hematologic therapy for metastatic disease * No prior abdominal radiotherapy * No concurrent corticosteroids as anti-emetic therapy * No other concurrent anticoagulation
References
Publications (1)
- DERIVEDRutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5. PMID 33337539