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
Conditionspatients with muscle invasive transitional cell carcinoma of the bladderMedDRA version: 12.1Level: LLTClassification code 10005017Term: Bladder carcinoma stage 0, with cancer in situMedDRA version: 12.1Level: LLTClassification code 10005019Term: Bladder carcinoma stage I, with cancer in situMedDRA version: 12.1Level: LLTClassification code 10005021Term: Bladder carcinoma stage II
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.
Investigators
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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