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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Gemcitabine
Radiotherapy
Tarceva
Oxaliplatin
Sponsored by
Institut Català d'Oncologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring neoadjuvant treatment, borderline resectability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Català d'Oncologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QT + QRT

Arm Description

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).

Outcomes

Primary Outcome Measures

Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.
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.

Secondary Outcome Measures

Median overall survival.
To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant).
Rate of resections with engative margins and complete pathological response.
To determine the rate of negative margin resections and complete pathological response (cPR).
Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9)
To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9).
Ratio of objective responses (RECIST).
To determine the ratio of objective responses according to RECIST criteria.
Prognosis accuracy of serum protein profiles
To determine the prognosis accuracy of serum protein profiles in these subjects.
Viability of the collection of pre-treatment tumor samples
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
To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.

Full Information

First Posted
January 11, 2012
Last Updated
August 28, 2017
Sponsor
Institut Català d'Oncologia
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1. Study Identification

Unique Protocol Identification Number
NCT01531712
Brief Title
Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to a low recruitment rate since start of recruitment period.
Study Start Date
February 10, 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Català d'Oncologia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
neoadjuvant treatment, borderline resectability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QT + QRT
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
gemzar
Intervention Description
1000mg/m2 / / 40mg/m2
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
50.4 Gy
Intervention Type
Drug
Intervention Name(s)
Tarceva
Other Intervention Name(s)
Erlotinib
Intervention Description
100mg/day
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
ELOXATIN
Intervention Description
100mg/m2 (only in QT)
Primary Outcome Measure Information:
Title
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.
Description
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.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Median overall survival.
Description
To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant).
Time Frame
Two years
Title
Rate of resections with engative margins and complete pathological response.
Description
To determine the rate of negative margin resections and complete pathological response (cPR).
Time Frame
Two years
Title
Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9)
Description
To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9).
Time Frame
Two years
Title
Ratio of objective responses (RECIST).
Description
To determine the ratio of objective responses according to RECIST criteria.
Time Frame
Two years
Title
Prognosis accuracy of serum protein profiles
Description
To determine the prognosis accuracy of serum protein profiles in these subjects.
Time Frame
Two years
Title
Viability of the collection of pre-treatment tumor samples
Description
To determine the feasibility of the collection of pre-treatment (baseline) tumor samples and to set pathological correlations with the response after neoadyuvant treatment.
Time Frame
Two years
Title
Adverse events
Description
To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berta Laquente, MD
Organizational Affiliation
ICO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Català d'Oncologia
City
L'Hospitalet
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

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

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