Pancreatic head Cancer MedDRA version: 7.0 Level: LLT Classification code 10007071
Conditions
Interventions
Trade Name: Gemzar
Product Name: Gemcitabine (Gemzar)
Product Code: LY188011
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
CAS Number: 0095058814
Concentration unit: mg mi
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: History of pancreas head adenocarcinoma with R0 pancreaticoduodenectomy Documented histological examination of surgical margins including retroperitoneal margin. The examination must have been performed during the surgical process and by using frozen sections. Proper documentation related to the number of lymph nodes ( 9.0 g/dl or 5.6 mmol/L, platelets > 150000 /mm3 , WBC > 3500/mm3 Abdominal spiral CT scan (with contrast enhancement) performed after surgery and/or a spiral CT scan performed before surgery but not older than 8 weeks at the time of randomization Age > or = 18 ECOG/WHO PS =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: No previous or coexistant malignant disease except BCC of the skin or carcinoma in situ of the cervix No previous chemotherapy or radiotherapy Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial No periampullary cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: The study itself is split into two sequential steps: Feasibility step including a randomization to study arms. Such a randomization during the feasibility step is required - to compare events observed in patients under protocol treatment vs events observed in patients receiving chemotherapy alone, - to more quickly reach the target of the possible Phase III step. Phase III step including a randomization to study arms The primary objective of the feasibility step will be to assess the feasibility and tolerability of the experimental arm in order to decide whether the randomized Phase III step can be or not carried out. The primary objective of the Phase III step will be to investigate if the experimental treatment consisting of gemcitabine followed by gemcitabine with concomitant radiation can extend the survival of patients as compared to gemcitabine alone.;Primary end point(s): Primary endpoints: ‘Feasibility’ Study: Feasibility: Full completion of the administration of the experimental treatment Tolerability: Acute and late toxicity. These toxicities will determine if the full completion of the experimental treatment is feasible. Phase III Study: Overall survival Secondary endpoints: Phase III Study: Disease free survival, sites of recurrence, toxicity, quality of life | — |
Countries
Germany
Outcome results
None listed