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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 November 2012 |
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Main ID: |
NCT01389440 |
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Date of registration:
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01/07/2011 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer
GEMCAD1003 |
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Scientific title:
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Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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24 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01389440 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Joan Maurel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Clínic de Barcelona |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Able to sign the inform consent form
- Age between 18-75 years
- Subject has not undergone any chemotherapy or radiotherapy previously
- Functional status o-1 (ECOG scale)
- Satisfy all radiological inclusion criteria (MSCT performed 28 days before the
treatment starts and a centralized evaluation)
- Patients with a cytologically confirmed diagnosis of pancreatic
adenocarcinoma(preferably by EUS)
- Appropriate analytical as inclusion criteria (7 days before the treatment starts):
- bone marrow status: neutrophils = 1,500x10^9/L; platelets = 100x10^9/L; hemoglobin =
9g/dL.
- INR = 1.5 and PTT = 1.5 x upper range of normal.
- Bilirubin = 5 mg/dL
- Albumin> 34 g/L
- Renal function: creatinine = 1.5 mg/dL and creatinine clearance> 50ml/min
Exclusion Criteria:
- patients treated with any of the study's drugs
- patients who has develop other primary tumors in 5 years prior to the inclusion at
the clinical trial, except for cervix carcinoma in situ or basal cell skin cancer
which have been treated properly.
- significant clinical cardiovascular disease: stroke (= 6 months before the study
inclusion), heart attack (= 6 months before inclusion), unstable ango pectoris,
congestive heart failure second grade or higher of the New York Heart Association
(NYHA) or serious cardiac arrhythmia requiring medication, uncontrolled hypertension
- Total o partial bowel obstruction
- Chronic diarrhea
- Current treatment with another investigational drug or participation in another
clinical trial within 30 days prior to inclusion.
- Known hypersensitivity to any of the study drugs or their components
- Currently o recent therapeutic treatment (opposite to prophylactic) with oral or
parenteral anticoagulants (full dose) or thrombolytic agents. Patients who receive
(or are candidates to receive) anticoagulants for prophylaxis of cardiovascular risk,
should continue (or begin) treatment at baseline
- Thromboembolic event history or bleeding in the 6 months prior to treatment.
- Evidence of bleeding diathesis or coagulopathy.
- Serious problems in wounds healing, ulcers or bone fractures.
- Major surgery, open biopsy or significant traumatic injury 28 days before treatment.
- Any other disease, metabolic disorder, physical examination findings or clinical
laboratory that provides reasonable evidence for suspecting a disease or condition
for which it is contraindicated or patient an experimental drug at high risk of
experiencing complications related to treatment .
- Patients undergoing with organ allografts requiring immunosuppressive treatment.
- Pregnant or breastfeeding woman. It requires a negative pregnancy test (serum or
urine) within 7 days before previous to treatment.
- Men and women of childbearing potential (including women who have had their last
menstrual period in less than 2 years) not using effective contraception precautions
- Positive HIV status
- Addiction to alcohol or other drugs
- Known liver cirrhosis
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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Pancreatic Adenocarcinoma
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Intervention(s)
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Drug: Gemcitabine and Erlotinib
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Primary Outcome(s)
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Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection
[Time Frame: 3 years]
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Secondary Outcome(s)
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Evaluate the overall survival time
[Time Frame: 3 years]
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Evaluate the pathological regression stage (primary tumor and lymphatic nodes)
[Time Frame: 3 years]
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Evaluate the percentage of lymphatic nodes involved
[Time Frame: 3 years]
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Evaluate the percentage of lymphatic nodes removed
[Time Frame: 3 years]
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Evaluate the percentage of resectability
[Time Frame: 3 years]
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Evaluate the response rate using RECIST criteria
[Time Frame: 3 years]
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Measure the progression free survival (time from the inclusion date to the progression of the disease or death)
[Time Frame: 3 years]
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Relate RECIST criteria with the pathological regress stage
[Time Frame: 3 years]
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To describe the safety of the treatment
[Time Frame: 3 years]
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Secondary ID(s)
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2010-021738-72
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GEMCAD1003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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