Clinical trial · Interventional
Chemotherapy With or Without Enoxaparin in Pancreatic Cancer
A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)
NCT00785421CI-TRIAL-00016565PROSPECTcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm. N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy with LMWH - enoxaparin | Drug | — | UNRESOLVED |
| enoxaparin | Drug | — | UNRESOLVED |
| only chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Patients with KPS \> 80% and normal kidney function receive GFFC + LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with KPS \< 80 % and increased creatinin plasma levels (\>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) + Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) + Enoxaparin 40mg/d s.c.
- interventionNames
- Drug: enoxaparin
- Drug: chemotherapy with LMWH - enoxaparin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Patients with KPS \> 80% and normal kidney function receive GFFC - LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w - Enoxaparin 1mg/kg daily s.c.). Pts with KPS \< 80 % and increased creatinin plasma levels (\>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) - Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) - Enoxaparin 40mg/d s.c.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histological or cytological pancreatic carcinoma, stage IV A, b * no preceding radio or chemotherapy of the primarius or the reference lesions * Karnofsky performance status ≥ 60% * measurable tumor lesion by spiral CT or MRT not older than 14 days * no deep venous thrombosis within the last 2 years * patient compliance and geographical proximity of the residence, which make an adequate follow up possible * sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l * signed informed consent * minimum age of 18 years * women/men must provide sufficient pregnancy prevention Exclusion Criteria: * preexisting indication for anti-coagulation of other reason * bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks) * body weight \< 45 kg and/or \> 100 kg * pregnancy or insufficient preventing methods in the study process * serious illness, which are incompatible with a study participation * hypersensitivity to study drugs * patients with serious kidney malfunction (Creatininclearance \< 30 ml/min)
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