E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with small cell lung cancer, who are going to receive chemotherapy treatment with a platinum- and topoisomeras inhibitor containing regimen. |
Patienter med småcellig lungcancer som skall erhålla kemoterapi med en platinum- och topoisomerashämmare regim. |
|
E.1.1.1 | Medical condition in easily understood language |
Small cell lung cancer. |
Småcellig lungcancer. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041067 |
E.1.2 | Term | Small cell lung cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective with the study is to evaluate treatment with chemotherapy with a platinum- and a topoisomeras inhibitor containing regimen versus treatment with the same chemotherapy with addition of enoxaparin comparing overall survival. |
Att utvärdera huruvida behandling med kemoterapi med en platinum- och en topoisomerashämmande regim, samt med tillägg av enoxaparin gentemot inget tillägg av enoxaparin, gen en förläng totalöverlevnad. |
|
E.2.2 | Secondary objectives of the trial |
Second objectives are:
To evaluate toxicity
To evaluate clinically significant haemorrhagia
To evaluate progression free survival
To evaluate thromboembolic events
To perform translational research |
Utvärdera toxicitet
Utvärdering av kliniska signifikant blödning
Att utvärdera progressionsfri överlevnad
Att utvärdera tromboemboliska händelser
Translationell forskning |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologically or cytologically verified small cell lung cancer, all stages
WHO Performance Status 0-3
Age 18 years or older
Intention and feasibility to treat with chemotherapy consisting of a platinum and a topoisomeras inhibitor
Platelets over 100 x 10 9/L
PK (prothrombine komplex) INR and APTT within normal ranges
Signed informed concent |
Histologiskt eller cytologiskt verifierad småcellig lungcancer, samtliga stadier
WHO performance status 0-3
Ålder över 18 år
Planeras för behandling med en platinum- och en topoisomerasinhiberande regim
Trombocyter överstigande 100 x 10 9/L
PK (prothrombine komplex) INR och APTT inom normalgränser
Signerat samtycke |
|
E.4 | Principal exclusion criteria |
Prior systemic chemotherapy for lung cancer
Concomitant anticoagulation treatment, except for ASA or clopidogrel
Active overt bleeding of clinical importance or at high risk
Any other known contraindication for enoxaparine (eg. hypersensitivity against enoxaparine and its derivates
Pregnancy or breast feeding
Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period
Treatment with any other investigational agent, or participation in any other clinical trial |
Tidigare kemoterapi vid lungcancer
Samtidig antikoagulantiabehandlingf, förutom ASA och clopidogrel
Aktiv blödning, eller risk för sådan
Känd kontraindikation mot enoxaparin
Gravid eller ammande
Fertila patienter ovilliga att använda adekvat antikonception
Behandling med annat studieläkemedel, eller deltagande i annan klinisk prövning |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate that addition of enoxaparine to standard chemotherapy treatment containing a platinum- and a topoisomeras inhibitor drug results in a significant increase in overall survival. |
Att visa, att tillägg av enoxaparin till standard kemoterapi innehållande en platinum- och en topoisomerashämmande regim ger en signifikant förlängning av den totala överlevnaden. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During study treatment, at follow up 2 and 12 months after end of treatment, and then untill patients death. |
Fortlöpande under studiebehandling, vid uppföljning 2 och 12 månader efter avslutad behandling, sedan fram till att patienten avlider. |
|
E.5.2 | Secondary end point(s) |
Toxicity
Clinically significant hemorrhage
Progression free survival
Thromboembolic events
Relation between different serum- and tumour markers and prognosis with or without enoxaparin |
Toxicitet
Kliniskt signifikanta blödningar
Progressionsfri överlevnad
Tromboemboliska händelser
Relationen mellan olika serum- och tumörmarkörer och prognos med eller utan tillägg av enoxaparin |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During study treatment, at follow up 2 and 12 months after end of treatment. |
Fortlöpande under studiebehandling, vid uppföljning 2 och 12 månader efter avslutad behandling. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Translational research |
Translationell forskning |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
After end of study regardless of reason, except withdrawn concent, patients will perform follow up visits 3 weeks after last chemotherapy treatment, 2 months after last treatment and a final visit after 12 months. |
Efter fullföljd studiebehandling, kommer deltagande patienter på uppföljning 3 veckor efter avslutad behandling, efter 2 månader, samt efter 12 månader efter sista behandling. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |