Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284778
Status:
COMPLETED
Last Update Posted:
2010-03-29
First Post:
2006-01-31
Brief Title:
Pharmaco-economic Study of a Second Line Treatment in Advanced Non Small Cell Lung Cancer
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
A Randomized Cost-minimization Trial Comparing Pemetrexed Alimta Versus Docetaxel Taxotere as Second Line Treatment in Advanced Non Small Cell Lung Cancer NSCLC Study 05-06 of Groupe Français de Pneumo-Cancérologie GFPC
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established The two treatments of reference are pemetrexed alimta and docetaxel taxotere Effectiveness and toxicity of the two drugs are largely documented in the literature
Economic analyses are currently one of the criteria used in medical decision beside effectiveness quality of life and toxicities
However Economical comparison shows significant variations in the acquisition costs of the two drugs Consequently it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment
As there is no difference in the effectiveness between the two treatments a cost-minimization analysis will be carried out to appreciate the ratio benefitrisks from an economical point of view payer
Economic analyses are currently one of the criteria used in medical decision beside effectiveness quality of life and toxicities
However Economical comparison shows significant variations in the acquisition costs of the two drugs Consequently it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment
As there is no difference in the effectiveness between the two treatments a cost-minimization analysis will be carried out to appreciate the ratio benefitrisks from an economical point of view payer
Detailed Description:
The main objective of this trial is of to compare economically the use of pemetrexed alimta in 2nd line chemotherapy in advanced non-small cell lung cancer versus docetaxel taxotere
150 patients will be selected for this trial which after checking the eligibility criteria will be randomized in two arms
Arm A Taxotere 75 mgm² every 3 weeks
Arm B Alimta 500 mgm² every 3 weeks
Inclusion assessment
Clinical signs
Blood cell count renal and hepatic function within 8 days
Chest X ray CT scan or MRI scan abdominal echography andor abdominal scan within 28 days
Brain scan bone scintigraphy andor bone x ray within 28 days
Bronchial endoscopy within 28 days
EKG echocardiography according to history
Follow-up assessment
1 At each cycle
Clinical signs
Blood cell count at D1 D8 D15
Creatinine serum electrolytes K Ca SGOT SGPT total bilirubin LDH alkaline phosphate total protein and albumin EKG Chest X-ray at D1
2 Follow-up each 2 months till PD
3 End of trial Complete tumor assessment
4 Each objective response may be confirm 4 weeks later
Length ot the study
Patients in each arm will be treated until progression or toxicity or decision to stop the trial
Responder patient will be treated until 6 cycles The follow-up assessment will be carried out each 2 months
Response assessment According to RECIST criteria
Resource consumption
1 Recording of volumes
All the medication quantities will be recorded in mg The chemotherapeutic products will be recorded in mg All the concomitant treatments RHO anti-emetics growth factors antibiotics or adverse event treatments will be notified
Hospitalizations for treatment and their categories inpatient outpatient home based treatment will be noted
All the hospitalizations for adverse events will be recorded and their category Grade 1-2 adverse events will be notified in the case report form Hospitalizations for disease complications or progressions curative or palliative radiation will be recorded
2 Cost calculation
All hospitalisations will be valued by DRGs or day hospitalisation prices according to the country Ambulatory care will be valued by appropriate country prices The drug price will be done by pharmaceutical companies
150 patients will be selected for this trial which after checking the eligibility criteria will be randomized in two arms
Arm A Taxotere 75 mgm² every 3 weeks
Arm B Alimta 500 mgm² every 3 weeks
Inclusion assessment
Clinical signs
Blood cell count renal and hepatic function within 8 days
Chest X ray CT scan or MRI scan abdominal echography andor abdominal scan within 28 days
Brain scan bone scintigraphy andor bone x ray within 28 days
Bronchial endoscopy within 28 days
EKG echocardiography according to history
Follow-up assessment
1 At each cycle
Clinical signs
Blood cell count at D1 D8 D15
Creatinine serum electrolytes K Ca SGOT SGPT total bilirubin LDH alkaline phosphate total protein and albumin EKG Chest X-ray at D1
2 Follow-up each 2 months till PD
3 End of trial Complete tumor assessment
4 Each objective response may be confirm 4 weeks later
Length ot the study
Patients in each arm will be treated until progression or toxicity or decision to stop the trial
Responder patient will be treated until 6 cycles The follow-up assessment will be carried out each 2 months
Response assessment According to RECIST criteria
Resource consumption
1 Recording of volumes
All the medication quantities will be recorded in mg The chemotherapeutic products will be recorded in mg All the concomitant treatments RHO anti-emetics growth factors antibiotics or adverse event treatments will be notified
Hospitalizations for treatment and their categories inpatient outpatient home based treatment will be noted
All the hospitalizations for adverse events will be recorded and their category Grade 1-2 adverse events will be notified in the case report form Hospitalizations for disease complications or progressions curative or palliative radiation will be recorded
2 Cost calculation
All hospitalisations will be valued by DRGs or day hospitalisation prices according to the country Ambulatory care will be valued by appropriate country prices The drug price will be done by pharmaceutical companies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None