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 个研究点目标入组 31 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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
•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 normal.
•Adequate follow-up possibilities for at least two years.

•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

发起方

Antoni van Leeuwenhoek Ziekenhuis