Spots Global Cancer Trial Database for ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
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Trial Identification
Brief Title: ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
Official Title: ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY
Study ID: NCT04661826
Interventions
Study Description
Brief Summary: The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
Detailed Description: This study will investigate the preliminary activity of Oncofid-P-B administered by intravescical route at the Recommended Dose of 600 mg, once a week, for six weeks evaluating the ablative activity on a papillary marker tumor in patients suffering from non-muscle invasive cancer of the bladder. When a patient will present a Complete Response at the end of the six weekly administration of Oncofid-P-B , he/she can enter a second phase of the study defined maintenance phase. During this phase, the patients will be treated with the study drug administered by intravesical infusion once a month for 2 cycles of treatment with the duration of 6 months separated by a period during which study drug will not be administered, due to the necessity to perform histological evaluation of efficacy. This scheme will follow a clinical usual approach for the maintenance treatment of patients suffering from non-muscle invasive cancer of the bladder. Complete Response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other site and negative cytology.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi, Essen, , Germany
Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Praxisklinik Urologie Rhein-Ruhr, Mülheim, , Germany
A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi, Bari, , Italy
A.O. Spedali Civili di Brescia - Dipartimento di Urologia, Brescia, , Italy
Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria, Pisa, , Italy
Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica, Roma, , Italy
A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I, Torino, , Italy
Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain
Hospital del Henares, Coslada, Madrid, Spain
Tenerife Hospital Universitario de Canarias, La Laguna, Tenerife, Spain
Hospital Del Mar, Barcelona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Instituto Valenciano de Oncologià, Valencia, , Spain
Contact Details
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