Clinical trial · Interventional
Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
NCT00519805CI-TRIAL-00005333unknownPhase 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)
RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer. PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dalteparin | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (9)
- measure
- Venous thrombotic event-free survival
- measure
- Serious adverse events
- measure
- Metastasis-free survival
- measure
- Toxicity
- measure
- Quality of life as measured by EQ-5D
- measure
- Breathlessness (dyspnea) as measured by the Cancer Dyspnea Scale
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks * No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site) * No clinically apparent brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Platelet count ≥ 100,000/mm³ * Serum creatinine ≤ 150 µmol/L * Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver * Not pregnant or nursing * Fertile female patients must use effective contraception (if sexually active) * No hemorrhagic stroke within the past 3 months * No known bleeding disorder * No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention) * No central venous catheter requiring the use of thromboprophylaxis * No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis) * No prior illness likely to interfere with study treatment or comparisons PRIOR CONCURRENT THERAPY: * No prior treatment likely to interfere with study treatment or comparisons * More than 12 months since prior and no concurrent therapeutic anticoagulation * No concurrent ketorolac (Toradol®)
References
Publications (2)
- RESULTGriffiths GO, Burns S, Noble SI, Macbeth FR, Cohen D, Maughan TS. FRAGMATIC: a randomised phase III clinical trial investigating the effect of fragmin added to standard therapy in patients with lung cancer. BMC Cancer. 2009 Oct 6;9:355. doi: 10.1186/1471-2407-9-355. PMID 19807917
- 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