E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with muscle invasive transitional cell carcinoma of the bladder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005017 |
E.1.2 | Term | Bladder carcinoma stage 0, with cancer in situ |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005019 |
E.1.2 | Term | Bladder carcinoma stage I, with cancer in situ |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005021 |
E.1.2 | Term | Bladder carcinoma stage II |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective is to evaluate the safety of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to investigate the efficacy of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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 normal. Adequate follow-up possibilities for at least two years.
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E.4 | Principal 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 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Acute Toxicity rate during radiotherapy with Panitumumab treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial is after 2 years FU (last visit). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |