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Clinical Trials/EUCTR2009-018246-38-NL
EUCTR2009-018246-38-NL
Active, not recruiting
Not Applicable

Phase II trial evaluating combined image guided radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder

Antoni van Leeuwenhoek Ziekenhuis0 sitesMay 12, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
patients with muscle invasive transitional cell carcinoma of the bladder
Sponsor
Antoni van Leeuwenhoek Ziekenhuis
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 12, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Antoni van Leeuwenhoek Ziekenhuis

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria
  • Signed written informed consent.
  • Histologically confirmed bladder carcinoma stage (including previous treatment):
  • T2 N0 M0, refusing surgery and not eligible for brachytherapy
  • T3\-4a N0 M0
  • T1\-4a pN1 M0: with no evidence of lymphnode disease as assessed by CT\-scan
  • and pN1 before neoadjuvant chemotherapy as assessed by lymphadenectomy. CR
  • or PR following neoadjuvant chemotherapy as assessed by CT\-scan.
  • T1\-4a N1\-2 M0 with evidence of lymphnode disease prior to chemotherapy as
  • assessed by CT\-scan and pN0\-1 after neoadjuvant chemotherapy as assessed by

Exclusion Criteria

  • Evidence of M\+ (all patients will undergo a pelvic lymphadenectomy prior to
  • chemoradiation).
  • Prior chemotherapy or radiotherapy to the pelvis.
  • Prior treatment with anti EGFr and/or anti VEGF treatment.
  • Previous malignancy except skin carcinoma (basal cell and squamous cell carcinoma).
  • Candidate for brachytherapy.
  • No adequate bladder function (functional capacity \< 100 cc, frequency \> 1/h).
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable
  • angina, symptomatic congestive heart failure, serious uncontrolled cardiac
  • arrhythmia) ? 1 year before enrollment/randomization.

Outcomes

Primary Outcomes

Not specified

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