Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer
- Registration Number
- NCT01389440
- Lead Sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Brief Summary
This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine, Erlotinib and radiotherapy Gemcitabine and Erlotinib Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy
- Primary Outcome Measures
Name Time Method Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection 3 years
- Secondary Outcome Measures
Name Time Method Evaluate the percentage of resectability 3 years To describe the safety of the treatment 3 years Based in safety population, all safety parameters will be analyzed and they will be recorded in lists and spread sheets. Most extreme intensity will be used for the notification of adverse events.
Safety population will include all subjects that have taken at least one study medication dose.Evaluate the response rate using RECIST criteria 3 years Evaluate the percentage of lymphatic nodes removed 3 years Evaluate the percentage of lymphatic nodes involved 3 years Evaluate the pathological regression stage (primary tumor and lymphatic nodes) 3 years Relate RECIST criteria with the pathological regress stage 3 years Measure the progression free survival (time from the inclusion date to the progression of the disease or death) 3 years Evaluate the overall survival time 3 years
Trial Locations
- Locations (10)
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Instituto Catalán de Oncología
🇪🇸Girona, Spain
Institut Català d'Oncologia (ICO) de L'Hospitalet
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Santa Creu y Sant Pau, Hospital Sant Pau
🇪🇸Barcelona, Spain
Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital la Fe de Valencia
🇪🇸Valencia, Spain