Trial reportBMC cancer2014
Intensified chemotherapy and simultaneous treatment with heparin in outpatients with pancreatic cancer - the CONKO 004 pilot trial.
Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01945879 (Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer.), which is not on this map. Cited by 13 papers, 8 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer.
Who cites it
13 citing papers in PubMed, 8 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Anticoagulation for the initial treatment of venous thromboembolism in people with cancer.The Cochrane database of systematic reviews · 2021Pooled it
- Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy.The Cochrane database of systematic reviews · 2020Pooled it
- Anticoagulation for perioperative thromboprophylaxis in people with cancer.The Cochrane database of systematic reviews · 2018Pooled it
- Anticoagulation for the long-term treatment of venous thromboembolism in people with cancer.The Cochrane database of systematic reviews · 2018Pooled it
- Anticoagulation for people with cancer and central venous catheters.The Cochrane database of systematic reviews · 2018Pooled it
- Anticoagulation for the initial treatment of venous thromboembolism in people with cancer.The Cochrane database of systematic reviews · 2018Pooled it
- Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation.The Cochrane database of systematic reviews · 2017Pooled it
- Parenteral anticoagulation in ambulatory patients with cancer.The Cochrane database of systematic reviews · 2017Pooled it
- Direct oral anticoagulantsWorld journal of methodology · 2026Article
- Expanding the Role of Heparin Derivatives in Oncology: From Anticoagulation to Antitumor Activity.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Multifaceted role of heparin in oncology: from anticoagulation to anticancer mechanisms and clinical implications.Discover oncology · 2025Review
- The role of coagulome in the tumor immune microenvironment.Advanced drug delivery reviews · 2023Review
- Selected hemostatic parameters in patients with pancreatic tumors.American journal of translational research · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdvanced pancreatic cancer (APC), beside its high mortality, causes the highest rates of venous thromboembolic events (VTE). Enoxaparin, a low molecular weight heparin (LMWH), is effective in prevention and treatment of VTE. Some small studies indicated that this benefit might extend to patients with cancer and probably prolong survival due to independent mechanisms. We initiated this safety investigation to get feasibility information on intensified chemotherapy combined with LMWH in outpatients with APC treated in 1st line.
methodsThe trial was a prospective, open-label, single center investigation in outpatients with inoperable pancreatic cancer who were treated with intensified first-line chemotherapy along with concomitant application of subcutaneous LMWH. The combined chemotherapy consisted of gemcitabine 1 g/m2 (30 min), 5-FU 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), and Cisplatin 30 mg/m2 (90 min) on day 1 and 8; q3w for the first 12 weeks (GFFC) followed by gemcitabine alone in patients without cancer progression. The simultaneous application of prophylactic enoxaparin started on day 1 of chemotherapy with a fixed dose of 40 mg daily. Statistical analyses were performed using R 3.01 with software package CMPRSK and SPSS software v19.0.
resultsThe investigation was stopped after recruitment of 19 patients. At this time 15 patients had completed the required 12 weeks of treatment. Based on 71 cycles of GFFC + enoxaparin (median 4/pt [range: 2-4]) and 108 cycles of single-agent gemcitabine + enoxaparin (median 4/pt [range: 0-18]) the cumulative frequency of NCI-CTC toxicities grade 3/4 was below 10%. One case (5%) of a symptomatic non-lethal thromboembolic event was observed while receiving LMWH treatment. No severe bleeding event as defined in the protocol has been observed. The median overall survival was 10.05 [95% CI: 8.67-18.14] months.
conclusionsThe addition of enoxaparin to GFFC chemotherapy is feasible, safe and does not appear to affect the efficacy or the toxicity profile of the chemotherapy regimen in patients with advanced pancreatic adenocarcinoma. Based on these findings we have initiated the randomized CONKO-004 trial to examine whether enoxaparin reduces the incidence of thromboembolic events or increases overall outcome.
trial registrationClinical Trials NCT01945879.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.