NL-OMON34833
Completed
N/A
Phase I trial evaluating combined radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder - Bladder preservation with Panitumumab and radiotherapy
Antoni van Leeuwenhoek Ziekenhuis0 sites31 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- bladder cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 31
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 lymphadenectomy.
- •Karnofsky performance of \* 70 prior to chemotherapy and prior to combined
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.
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of
Outcomes
Primary Outcomes
Not specified
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