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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2015 |
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Main ID: |
NCT01454180 |
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Date of registration:
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11/10/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets
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Scientific title:
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Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01454180 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Manuel Hidalgo, M.D.,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CNIO |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histological or cytological diagnosis of pancreatic carcinoma.
- Patients> 18 years.
- Measurable or not measurable disease.
- Life expectancy> 3 months at the discretion of the investigator.
- Good general condition determined by the ECOG scale (score 0-1)
- Candidate for first-line systemic chemotherapy according to standard practice.
- Availability of tumor tissue or opportunity for tumor biopsy for the - determination
of biomarkers and their correlation with treatment.
- Adequate hematologic function: ANC> 1.5 x 103 / L, absolute count of platelets> 100 x
109 / L, normal values of INR and PTT.
- Adequate liver function: total serum bilirubin <2 mg / dL, ALT and AST <3 times the
upper limit established by the laboratory (LSR) or <5 LSR in patients with liver
metastases.
- Adequate renal function: serum creatinine <1.5 LSR.
Exclusion Criteria:
- Patients who have received prior chemotherapy for advanced pancreatic carcinoma. Will
not result excluding patients who had previously received adjuvant treatment with
gemcitabine or fluoropyrimidines. Also not will be excluded patients who had
previously received preoperative neoadjuvant treatment for localized disease with
chemotherapy and / or radiotherapy.
- Patients for whom is contraindicated the administration of either drug used in
first-line treatment for pancreatic cancer: Gemcitabine, 5'Fluouracilo, Leucovorin,
Capecitabine, Oxaliplatin, Irinotecan, Erlotinib.
- Pregnant or breastfeeding women
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Pancreatic Carcinoma
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Intervention(s)
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Drug: Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI
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Drug: gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.
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Primary Outcome(s)
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Overall survival
[Time Frame: 12 months]
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Secondary ID(s)
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CNIO-GI-01-2011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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