Pancreas Cancer
Conditions
Keywords
adenocarcinoma, pancreatic head
Brief summary
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy). This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
Interventions
DRUGNeoadjuvant chemotherapy
four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
PROCEDUREsurgery and Adjuvant chemotherapy
surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy) * T1-3, Nx, M0 (UICC 6th version, 2002) * infiltration of the portal vein (\<180°) is not an exclusion criterion * cytologic or histologic confirmation of adenocarcinoma * age \>18 years * written informed consent
Exclusion criteria
* contraindication for Whipple procedure * an infiltration \>180° of the portal vein * abutment of the tumor to the superior mesenteric artery * infiltration of the superior mesenteric artery or the celiac trunk * chronic neuropathy \> grade 2 * WHO performance score \>2 * uncorrectable cholestasis (bilirubin \> 100mmol/l despite drainage attempts for more than four weeks prior to inclusion) * female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms) * pregnant or lactating women * mental or organic disorders which could interfere with giving informed consent or receiving treatments * Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer * percutaneous biopsy of the primary tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | from date of randomization until date of progression, assessed up to 5 years | period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| histology | at 6 months | histological response, |
| overall survival | From date of randomization until date of death, assessed up to 5 years | time from date of inclusion to date of death |
| complication | until 6 months | complication rates after surgery, |
Countries
France
Outcome results
None listed