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Clinical Trials/EUCTR2007-004535-33-DE
EUCTR2007-004535-33-DE
Active, not recruiting
Not Applicable

Phase II study on curative resectability of not optimally resectable liver and/or lung metastases from colorectal carcinoma (CRC) under intensified chemotherapy (FLOFOXIRI/Bevacizumab). - APRIORI

niversitätsklinikum Heidelberg0 sitesMarch 9, 2009
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DrugsOxaliplatin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitätsklinikum Heidelberg
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 9, 2009
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Heidelberg

Eligibility Criteria

Inclusion Criteria

  • •1\. Age \=18 years
  • •2\. Indication:
  • •\- Histologically confirmed advanced colorectal carcinoma of UICC Stages IV with liver and/or lung only metastases, which are not optimally resectable.
  • •\- Measurable disease according to RECIST criteria.
  • •\- In case of liver metastases: 70% liver replacement and/or \> 6 segments tumor involved, and/or involvement of all three hepatic veins, and/or involvement of the right and left portal pedical, and/ or involvement of the vena cava.
  • •\- In case of lung metastases: No tumor with direct infiltration of myocardium, esophageous, spine or intrapericardial large vessels. Preoperative data indicate a significant loss of pulmonary function after pulmonary metastasectomy with severe impairment of quality of life.
  • •3\. ECOG performance status of \< 2\.
  • •4\. Life expectancy of \> 3 months
  • •5\. Laboratory parameters:
  • •Proteinuria at baseline:

Exclusion Criteria

  • •1\. Past or current history of malignancies other than colorectal carcinoma. Patients with curatively treated basal and squamous cell carcinoma of the skin and/or in\-situ carcinoma of the cervix are eligible.
  • •2\. Previous chemotherapy.
  • •3\. Extrahepatic and/or extrapulmonary metastases except of the initially removed lymph node metastases.
  • •4\. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke).
  • •5\.Major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to study treatment start (wound healing has to be completed), or anticipation of the need for major surgical procedure during the course of the study.
  • •6\. Evidence of bleeding diathesis or coagulopathy
  • •7\. Serious, non\-healing wound, ulcer, or bone fracture
  • •8\. Treatment with investigational agents or participation in clinical trials within 30 days before study entry.
  • •9\. Clinically significant (i.e. active) cardiovascular disease, e.g., uncontrolled hypertension, cerebrovascular accidents (\= 6 months prior to treatment start), myocardial infarction (\= 6 months prior to treatment start), unstable angina, New York Heart Association (NYHA) grade \>\= II, congestive heart failure, serious cardiac arrhythmia requiring medication.
  • •10\. Current or recent serious polyneuropathy (grade \>\= 1 according to NCI CTCAE v3\.0 criteria; exception: absence of tendon reflexes).

Outcomes

Primary Outcomes

Not specified

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