|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00303758 |
|
Date of registration:
|
15/03/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
|
|
Scientific title:
|
Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression |
|
Date of first enrolment:
|
October 2005 |
|
Target sample size:
|
202 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00303758 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Jean-Francois Seitz, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU de la Timone |
|
|
Name:
|
Pascal Hammel, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hopital Beaujon |
|
|
Name:
|
Jean-Louis Legoux, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hopital Haut Leveque |
|
|
Key inclusion & exclusion criteria
|
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla
- Metastatic disease
- Unresectable disease
- Measurable disease, meeting the following criteria:
- No prior radiotherapy to the only site of measurable disease
- Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods
- No brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 2 months
- No contraindication to chemotherapy
- Creatinine clearance > 60 mL/min
- Absolute neutrophil count = 1,500/mm³
- Platelet count = 100,000/mm³
- Alkaline phosphatase < 5 times normal
- Bilirubin = 3 mg/dL
- No coronary insufficiency
- No symptomatic cardiac disease
- Good hydration possible
- No Child-Pugh class B or C cirrhosis
- No other malignancy except for basal cell skin cancer or carcinoma in situ of the
cervix
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior palliative or adjuvant chemotherapy
- At least 4 weeks since prior radiotherapy
- No radiotherapy during or for 4 weeks after study therapy
- No other concurrent anticancer therapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pancreatic Cancer
|
|
Intervention(s)
|
|
Drug: cisplatin
|
|
Drug: fluorouracil
|
|
Drug: gemcitabine hydrochloride
|
|
Drug: leucovorin calcium
|
|
Primary Outcome(s)
|
|
Overall survival
[Time Frame: No]
|
|
Secondary Outcome(s)
|
|
Duration of hospitalization
[Time Frame: No]
|
|
Percentage of patients needing second-line therapy
[Time Frame: No]
|
|
Progression-free survival
[Time Frame: No]
|
|
Quality of life
[Time Frame: No]
|
|
Toxicity
[Time Frame: Yes]
|
|
Secondary ID(s)
|
|
CDR0000453841
|
|
EU-20543
|
|
FFCD-0301
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|