Bladder carinoma, preservation, radiotherapy, Panitumumab
Conditions
Interventions
Patients with a T1 to a T4a bladder carcinoma might be eligible for this study (see protocol section 4.5). Baseline investigations, prior to treatment, will include history, concomitant drug use, bloo
Sponsors
NKI-AvL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent; 2. Histologically confirmed bladder carcinoma stage (including previous treatment): A. T2 N0 M0, refusing surgery and not eligible for brachytherapy; B. T3-4a N0 M0; C. 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; D. 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. 3. Karnofsky performance of 70 prior to chemotherapy and prior to combined Panitumumab/radiotherapy treatment; 4. Hematopoietic function: Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, leucocytes> 3,000/mm3 and hemoglobin ≥ 9 g/dL; 5. Hepatic function: Total bilirubin ≤ 1.5 times the upper normal limit (UNL), ASAT ≤ 2.5 x UNL and ALAT ≤ 2.5 x UNL; 6. Renal function: Creatinin clearance ≥ 50 mL/min (calculated clearance); 7. Metabolic function: Magnesium ≥ lower limit of normal and Calcium ≥ lower limit of normal; 8. Adequate follow-up possibilities for at least two years.
Exclusion criteria
Exclusion criteria: 1. Evidence of M+ (all patients will undergo a pelvic lymphadenectomy prior to chemoradiation); 2. Prior chemotherapy or radiotherapy to the pelvis; 3. Prior treatment with anti EGFr and/or anti VEGF treatment; 4. Previous malignancy except skin carcinoma (basal cell and squamous cell carcinoma); 5. Candidate for brachytherapy; 6. No adequate bladder function (functional capacity 1/h); 7. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization; 8. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan; 9. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment; 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Toxicity rate during radiotherapy with Panitumumab treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response rate at 3 months; 2. Local control rate at 6, 12, and 18 months, and at 2 years; 3. Bladder preservation rate; 4. Any grade 3 or 4 adverse event during and within one month after completion of therapy. | — |
Contacts
Public ContactAndré M. Bergman
Division of Internal Medicine (MOD) and Molecular Genetics Netherlands Cancer Institute (NKI-AvL) Plesmanlaan 121
Outcome results
None listed