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 个研究点开始时间: 2010年5月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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.
•a Karnofsky performance of more or equl 70 prior to chemotherapy and prior to
•combined Panitumumab/radiotherapy treatment.
•Hematopoietic function: Neutrophils = 1.5 x 109/L, platelets = 100 x 109/L,
•leucocytes> 3,000/mm3 and hemoglobin = 9 g/dL.
•Hepatic function: Total bilirubin = 1.5 times the upper normal limit (UNL), ASAT = 2.5
•x UNL and ALAT = 2.5 x UNL.
•Renal function: Creatinin clearance = 50 mL/min (calculated clearance).
•Metabolic function: Magnesium = lower limit of normal and Calcium = lower limit of
•Adequate follow-up possibilities for at least two years.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 interstitial lung disease on baseline chest CT scan.
•Subject pregnant or breast feeding, or planning to become pregnant within 6
•months after the end of treatment.
•Subject (male or female) is not willing to use highly effective methods of
•contraception (per institutional standard) during treatment and for 6 months (male
•or female) after the end of treatment.

发起方

Antoni van Leeuwenhoek Ziekenhuis