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In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saline solution | Placebo Comparator | Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours). |
|
| nadroparin calcium | Experimental | Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadroparin calcium | Drug | Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy | Events occurring during the four months of treatment plus 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival, at the end of study treatment | Events occurring during the four months of treatment plus 10 days | |
| Response to chemotherapy | Events occurring during the four months of treatment plus 10 days |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Agnelli, MD | Internal and Vascular Medicine University of Perigia (Italy) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology Department | Fabriano | Ancona | 60044 | Italy | ||
| Medical Oncology Department Oncology Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33337539 | Derived | Rutjes 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. | |
| 22013950 | Derived | Barni S, Labianca R, Agnelli G, Bonizzoni E, Verso M, Mandala M, Brighenti M, Petrelli F, Bianchini C, Perrone T, Gasparini G. Chemotherapy-associated thromboembolic risk in cancer outpatients and effect of nadroparin thromboprophylaxis: results of a retrospective analysis of the PROTECHT study. J Transl Med. 2011 Oct 20;9:179. doi: 10.1186/1479-5876-9-179. |
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| saline solution (placebo) | Drug | Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours). |
|
| For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal | Events occurring during the four months of treatment plus 10 days |
| Superficial thrombophlebitis of lower limbs | Events occurring during the four months of treatment plus 10 days |
| Asymptomatic thromboembolic events diagnosed during tests performed for other purposes | Events occurring during the four months of treatment plus 10 days |
| Safety (major bleeding, minor bleeding, other adverse events) | Events occurring during the four months of treatment plus 48 hours |
| Bari |
| Bari |
| 70126 |
| Italy |
| Medical Oncology Unit | Bergamo | Bergamo | 24100 | Italy |
| Medical Oncology Department | Treviglio | Bergamo | 24047 | Italy |
| Medical Oncology Department - Bellaria Hospital | Bologna | Bologna | 40139 | Italy |
| Medical Oncology Department - Businco Hospital | Cagliari | Cagliari | 09121 | Italy |
| Medical Oncology Department University of Cagliari | Cagliari | Cagliari | 09133 | Italy |
| Medical Oncology Department | Catanzaro | Catanzaro | 88100 | Italy |
| Medical Oncology Department | Cosenza | Cosenza | 87100 | Italy |
| Medical Oncology Department | Cremona | Cremona | 26100 | Italy |
| Medical Oncology Department | Ferrara | Ferrara | 44100 | Italy |
| Medical Oncology Department Careggi Hospital | Florence | Firenze | 50139 | Italy |
| Casa Sollievo dell Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Cancer institute of Romagna | Forlì | Forlì | 47100 | Italy |
| Medical Oncology Department | Latina | Latina | 04100 | Italy |
| Medical Oncology Department | Lecce | Lecce | 73100 | Italy |
| Medical Oncology Department | Lucca | Lucca | 55100 | Italy |
| Medical Oncology Department | Taormina | Messina | 98039 | Italy |
| Medical Oncology Department | Legnano | Milano | 20025 | Italy |
| University Bicocca | Milan | Milano | 20052 | Italy |
| Medical Oncology Department Fatebenefratelli Hospital | Milan | Milano | 20121 | Italy |
| Medical Oncology Department Policlinico | Milan | Milano | 20122 | Italy |
| Gynecology Oncology INT | Milan | Milano | 20133 | Italy |
| Medical Oncology Department San Carlo Hospital | Milan | Milano | 20153 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Medical Oncology Department | Camposampiero | Padova | 35012 | Italy |
| Medical Oncology Department Istituto Oncologico Veneto | Padova | Padova | 35128 | Italy |
| Medical Oncology Department | Palermo | Palermo | 90127 | Italy |
| Salvatore Maugeri Foundation | Pavia | Pavia | 27100 | Italy |
| Medical Oncology Department | Città di Castello | Perugia | 06012 | Italy |
| Medical Oncology Department | Perugia | Perugia | 06156 | Italy |
| Medical Oncology Department | Todi | Perugia | 06059 | Italy |
| Hematology and Oncology Department | Piacenza | Piacenza | 29100 | Italy |
| Medical Oncology Department - University of Pisa | Pisa | Pisa | 56126 | Italy |
| Medical Oncology Department | Ravenna | Ravenna | 48100 | Italy |
| Medical Oncology Department | Reggio Emilia | Reggio Emilia | 42100 | Italy |
| Medical Oncology Department - S Filippo Hospital | Roma | Roma | 00135 | Italy |
| Medical Oncology Department Regina Elena Institute | Roma | Roma | 00144 | Italy |
| Medical Oncology Department 3 Regina Elena Cancer Institute | Rome | Rome | 00144 | Italy |
| Onco-gynecology Department - Catholic University | Rome | Rome | 00168 | Italy |
| Medical Oncology Department | Sassari | Sassari | 07100 | Italy |
| Medical Oncology Department | Terni | Terni | 05100 | Italy |
| Medical Oncology Department San Luigi Hospital | Orbassano | Torino | 10043 | Italy |
| Oncology Department Molinette Hospital | Torino | Torino | 10126 | Italy |
| Medical Oncology Department | Varese | Varese | 21100 | Italy |
| Medical Oncology Department | Viterbo | Viterbo | 01100 | Italy |
| 19726226 | Derived | Agnelli G, Gussoni G, Bianchini C, Verso M, Mandala M, Cavanna L, Barni S, Labianca R, Buzzi F, Scambia G, Passalacqua R, Ricci S, Gasparini G, Lorusso V, Bonizzoni E, Tonato M; PROTECHT Investigators. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study. Lancet Oncol. 2009 Oct;10(10):943-9. doi: 10.1016/S1470-2045(09)70232-3. Epub 2009 Aug 31. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D013923 | Thromboembolism |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017762 | Nadroparin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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