Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT00261092
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven adenocarcinoma of the pancreas
* Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)
* Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors\>2cm using conventional CT scan or ≥1cm with spiral CT scan)
* No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted
* Karnofsky Performance Status (KPS) ≥60
* No known Central Nervous System metastases
* No sensory neuropathy at inclusion
* Biological and hematological evaluation \< 2 weeks prior to treatment administration:
* Neutrophils ≥ 1500/ mm3
* Platelets ≥ 100,000/mm3
* Alkaline phosphatases\< 5X ULN(upper Limits of Normal) and Bilirubin \< 1.5X ULN
* SGOT,SGPT \<2.5 X ULN if no liver metastasis
* SGOT,SGPT \<5 X ULN if liver metastasis
* Creatinine \< 1.5 X ULN
* Baseline imaging (CT scan or Magnetic Resonance Imaging) \<3 weeks before treatment administration
* Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
Exclusion Criteria:
* Corticotherapy except for anti-emetic purpose
* Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)
* Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
* Uncontrolled or persistent hypercalcemia
* History of significant neurologic or psychiatric disorders
* Vater ampulomas and biliary tract adenocarcinomas
* Other -non cured- malignancies
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00261092
Study Brief:
Protocol Section:
NCT00261092