|- candidate number||8463|
|- NTR Number||NTR2518|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-sep-2010|
|- Secondary IDs||NL32135.031.10 CCMO|
|- Public Title||A randomized trial comparing longstanding indwelling pleural catheters with pleurodesis as a frontline treatment for malignant pleural effusion.|
|- Scientific Title||A randomized trial comparing longstanding indwelling pleural catheters with pleurodesis as a frontline treatment for malignant pleural effusion.|
|- ACRONYM||IPC vs talc pleurodesis|
|- hypothesis||The observed improvement in palliative care (dyspnoea is the most prominent symptom) in the pleurodesis group is less than the improvement in the indwelling arm.|
|- Healt Condition(s) or Problem(s) studied||Malignant pleural effusion, IPC (indwelling pleural catheter), Talc pleurodesis|
|- Inclusion criteria||1. Symptomatic pleural effusion;|
2. Any histologically or cytologically proven malignancy;
3. Written informed consent;
4. Recurrence of pleural effusion within 6 months after last therapeutic thoracentesis.
|- Exclusion criteria||1. Other causes of pleural effusion than malignancy;|
2. Previous chemical or surgical pleurodesis;
3. Impaired immunity: Leucopenia <2.0 x 109/L, high dose corticosteriods (>=1 mg/kg);
4. Thrombocytopenia (<50 x 109/L).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2010|
|- planned closingdate||1-jul-2012|
|- Target number of participants||120|
|- Interventions||1. Thoracentesis;|
2. Talc pleurodesis;
3. Placement of indwelling pleural catheter.
|- Primary outcome||Patient reported dyspnoea at 4 to 6 weeks after the intervention, assessed by th Modified Borg scale.|
|- Secondary outcome||1. Number of emergency presentations at the outpatient clinic for reasons of symptomatic MPE after completion of the treatment;|
2. Number of interventions for MPE after completion of the MPE treatment;
3. The overall time of hospitalization because of MPE;
4. Patient reported dyspnoea and thoracic pain, directly following catheter placement and 3 and 6 months after randomization;
5. Quality of Life;
6. The treatment outcome at 1,3 and 6 months;
7. Overall treatment costs in relation to MPE;
8. Adverse Events;
9. Overall survival;
10. Detection of prognostic markers for the outcome of the intervention;
11. Development of a clinical decision rule for treatment of MPE.
|- Timepoints||1. First patient in 2010 Q3;|
2. Final patient in 2012 Q1;
3. Data lock 2012 Q3;
4. Reporting 2013 Q1.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.M. Heuvel, van den|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.M. Heuvel, van den|
|- Sponsor/Initiator ||Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) |
(Source(s) of Monetary or Material Support)
|- Publications||A final report will be prepared for publication in peer reviewed journals.|
Authorship will include investigators who have recruited at least 10% of the total number of evaluable patients and investigators who participated significantly to the translational research.
The authors sequence should usually reflect the input (like the number of evaluable patients enrolled) of/by the respective investigator.
Draft versions of abstracts or manuscripts must be made available to the co-authors before any presentation of results or submission for publication.
|- Brief summary||Consecutive 120 patients with symptomatic MPE will be registered in part 1 (thoracentesis) of the study. 80 patients (of the 120) with recurrent symptomatic MPE will be asked to participate in a randomized trial comparing the standard talc pleurodesis (arm A) with the experimental treatment, the indwelling catheter (arm B). Primairy endpoint of the study is the patient reported dyspnoea at 4 to 6 weeks after the intervention, assessed by the Modified Bord scale.|
|- Main changes (audit trail)|
|- RECORD||16-sep-2010 - 26-sep-2010|