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Clinical Trials/EUCTR2009-015402-19-BE
EUCTR2009-015402-19-BE
Active, not recruiting
Not Applicable

Chimiothérapie d’induction suivie d’une radiochimiothérapie préopératoire à base de cisplatine, 5FU et panitumumab dans le traitement des cancers oesogastriques avancés et opérables

B Erasme0 sites49 target enrollmentJanuary 7, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
B Erasme
Enrollment
49
Status
Active, not recruiting
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 7, 2010
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
B Erasme

Eligibility Criteria

Inclusion Criteria

  • Locally advanced gastric and EG junction adenocarcinoma with histological proof \> T2a\-N0 (including T2a\-T3\-T4 and N0 or N\+).
  • Patient \= 18 years of age.
  • Potentially resectable tumor.
  • Operable patient without major comorbidities (cardiovascular, pulmonary, neurological).
  • Adequate liver, renal and hematological functions.
  • Haematology:
  • oNeutrophil count \=1\.5x109/L
  • oPlatelet count \=100x109/L
  • oLeucocyte count \> 3,000/mm
  • o Hemoglobin \> 9 g/dL

Exclusion Criteria

  • Evidence of distant metastases including distant lymph nodes (including supraclavicular, hepatoduodenal, retropancreatic, mesenteric and paraaortic).
  • Patients with non operable tumor.
  • Prior therapy for upper GI cancer.
  • Other histological types than adenocarcinoma.
  • History of other primary cancer, unless:
  • oCuratively resected non\-melanomatous skin cancer
  • oCuratively treated cervical carcinoma in situ
  • oOther primary solid tumor curatively treated with no known active disease present and no treatment administered for \= 5 years before enrollment
  • Presence of peripheral neuropathy \> grade 1 according to CTCAE.
  • Presence of uncontrolled comorbidities.

Outcomes

Primary Outcomes

Not specified

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