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Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable

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ClinicalTrials.gov Identifier: NCT01531712
Recruitment Status : Terminated (Due to a low recruitment rate since start of recruitment period.)
First Posted : February 13, 2012
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Català d'Oncologia

Tracking Information
First Submitted Date  ICMJE January 11, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date August 29, 2017
Study Start Date  ICMJE February 10, 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy. [ Time Frame: Two years ]
Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemoradiotherapy with Gemcitabine and Tarceva.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
Primary outcome measure [ Time Frame: Two years ]
Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Gemcitabine and Tarceva.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
  • Median overall survival. [ Time Frame: Two years ]
    To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant).
  • Rate of resections with engative margins and complete pathological response. [ Time Frame: Two years ]
    To determine the rate of negative margin resections and complete pathological response (cPR).
  • Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9) [ Time Frame: Two years ]
    To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9).
  • Ratio of objective responses (RECIST). [ Time Frame: Two years ]
    To determine the ratio of objective responses according to RECIST criteria.
  • Prognosis accuracy of serum protein profiles [ Time Frame: Two years ]
    To determine the prognosis accuracy of serum protein profiles in these subjects.
  • Viability of the collection of pre-treatment tumor samples [ Time Frame: Two years ]
    To determine the feasibility of the collection of pre-treatment (baseline) tumor samples and to set pathological correlations with the response after neoadyuvant treatment.
  • Adverse events [ Time Frame: Two years ]
    To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Secondary outcome measure [ Time Frame: Two years ]
    Median overall survival.
  • Secondary outcome measure [ Time Frame: Two years ]
    Percentage of negative margin resections and complete pathological response.
  • Secondary outcome measure [ Time Frame: Two years ]
    Response rate to neoadjuvant treatment tumor markers.
  • Secondary outcome measure [ Time Frame: Two years ]
    Proportion of objective responses (RECIST).
  • Secondary outcome measure [ Time Frame: Two years ]
    Assessment of prognosis accuracy in serum protein profiles.
  • Secondary outcome measure [ Time Frame: Two years ]
    Assessment of the viability of the collection of pre-treatment tumor samples and to establish pathological correlations with response after treatment.
  • Secondary outcome measure [ Time Frame: Two years ]
    Adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable
Official Title  ICMJE Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability.
Brief Summary Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. The primary objective is to determine the resectability rate of patients with pancreas adenocarcinoma with borderline resectability determined radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy with Gemcitabine and Tarceva.
Detailed Description

Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop perioperative complications due to the complexity of surgery. In these patients there is also an increased risk of systemic relapse due to the advanced stage of the tumor as well as a higher possibility of having positive margins. Therefore, the treatment of these patients need to be decided based on a multidisciplinary strategy. Besides of that the use of systemic neoadjuvant chemotherapy as induction therapy, followed by sequential chemoradiotherapy is a very attractive therapeutic modality.

The neoadjuvant treatment offers the potential advantages of reducing the tumor stage, increasing resectability and decreasing postoperative complications.

The administration of chemotherapy and radiotherapy before surgery represent an strategy for early treatment of micrometastatic disease, present in most of these patients, and to identify patients with rapid progression of the disease.

For all the reasons above, the investigators consider it's of great interest to design new studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with neoadjuvant intention in patients with pancreas cancer locally advanced.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Gemcitabine
    1000mg/m2 / / 40mg/m2
    Other Name: gemzar
  • Radiation: Radiotherapy
    50.4 Gy
  • Drug: Tarceva
    100mg/day
    Other Name: Erlotinib
  • Drug: Oxaliplatin
    100mg/m2 (only in QT)
    Other Name: ELOXATIN
Study Arms  ICMJE Experimental: QT + QRT

Chemotherapy (6 cycles x 14 days): Gemcitabine 1000 mg/m2 (day 1) + Oxaliplatin 100 mg/m2 (day 2) + Tarceva 100 mg/day.

Chemoradiotherapy (5,5 weeks): Gemcitabine 40 mg/m2 (2 days/week) + Tarceva 100 mg/day + Radiotherapy (1,8 Gy/day x 28 doses, total dose: 50,4 Gy).

Interventions:
  • Drug: Gemcitabine
  • Radiation: Radiotherapy
  • Drug: Tarceva
  • Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 20, 2012)
6
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
25
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Before the beginning of the specific protocol procedures must be obtained and documented a written consent form. Patients must have sufficient capacity to understand and sign the consent form.
  • Exocrine pancreatic potentially resectable carcinoma, histologically confirmed.
  • Aged 18-75 years.
  • OMS functional state (FE) from 0-2 and Karnofsky functional state 70%.
  • Radiologically or measurable disease, defined as borderline resectability disease.
  • Appropriate biological parameters: neutrophils > 1.500/mL; platelets > 100.000/mL; hemoglobin > 10 g/dl.Serum creatinine < 1,5 x upper limit of normal (LSN); alkaline phosphatase < 3 x LSN and bilirubin < 1,5 x LSN; AST and ALT 2,5 x LSN.
  • Controlled biliary obstruction in all the patients before their inclusion in the study.
  • Absence of peripheral neuropathy grade 2.
  • Life expectancy of at least 3 months.

Exclusion Criteria:

  • Previous administration of chemotherapy, radiotherapy or any investigational agents for pancreatic cancer treatment.
  • Administration of other experimental treatment during this study or in the previous 6 months.
  • Pregnancy, inappropriate or unsafe use of contraceptive methods or women who are breast-feeding.
  • Clinically significant heart disease(for example: congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not properly controlled with medication or myocardial infarction in the last 12 months).
  • Presence of significant ophthalmologic anomaly, included: severe dry eye syndrome, Sjogren syndrome, dry keratoconjunctivitis, severe exposure keratopathy, conditions that might increase the risk of epithelium complications.
  • Patients with lack of physical integrity of the upper gastrointestinal tract or bad absorption syndromes or unable to ingest the tablets.
  • Other previous bad or concurrent diseases, with the exception of nonmelanoma skin cancer.
  • Medical or psychiatric pathologies that are severe or uncontrolled.
  • Distant metastases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531712
Other Study ID Numbers  ICMJE ICO-20431
2010-021872-27 ( EudraCT Number )
GEMERLOXA ( Other Identifier: ICO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Català d'Oncologia
Study Sponsor  ICMJE Institut Català d'Oncologia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Berta Laquente, MD ICO
PRS Account Institut Català d'Oncologia
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP