PREPARE
Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy
Rekrutierend
NCT-Nummer:
NCT03013946
Studienbeginn:
Januar 2017
Letztes Update:
15.06.2023
Wirkstoff:
-
Indikation (Clinical Trials):
Carcinoma, Carcinoma, Renal Cell
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
AIO-Studien-gGmbH
Collaborator:
Pfizer, Crolll Gmbh,
Studienleiter
Viktor Grünwald, Prof. Dr. Principal InvestigatorUniversitätsklinikum Essen
Kontakt
Mischo Kursar, Dr. Kontakt: Phone: +49 30 8145 344 Phone (ext.): 67 E-Mail: Mischo.Kursar@aio-studien-ggmbh.de» Kontaktdaten anzeigen
Johanna Homfeld Kontakt: Phone: +49 30 8145344 Phone (ext.): 72 E-Mail: johanna.homfeld@aio-studien-ggmbh.de» Kontaktdaten anzeigen
Studienlocations (3 von 34)
Regensburg Bayern Deutschland Frankfurt am Main Hessen Germany Fulda Göttingen Stolberg Nordrhein-Westfalen Bonn Essen Mainz Trier Rheinland-Pfalz Magdeburg Sachsen-Anhalt Wittenberg Markkleeberg Sachsen Lübeck Neumünster Schleswig-Holstein Erfurt Thüringen Amberg Berlin Dresden Goslar Niedersachsen Hannover Herzberg Kaiserslautern Landshut Mühlheim Münster Nürnberg Rostock Mecklenburg-Vorpommern Singen Baden-Württemberg Soest
Onkologisches Zentrum - Krankenhaus Barmherzige Brüder Regensburg Prüfeninger Straße 86 93049 Regensburg (Bayern) DeutschlandRekrutierend » Google-Maps Ansprechpartner: Heribert Stauder, MD Phone: 09413693309 E-Mail: heribert.stauder@barmherzige-regensburg.deheribert.stauder@barmherzige-regensburg.de » Ansprechpartner anzeigen Universitätsklinikum Frankfurt 60590 Frankfurt am Main (Hessen) GermanyNoch nicht rekrutierend » Google-Maps Ansprechpartner: Severine Banek, Dr. Phone: 069 630180072 E-Mail: severine.banek@kgu.de» Ansprechpartner anzeigen Darmzentrum Klinikum Fulda Pacelliallee 4 36043 Fulda DeutschlandNoch nicht rekrutierend » Google-Maps Ansprechpartner: Heinz-Gert Höffkes, Prof. Phone: 0926162480 E-Mail: hoeffkes.tumorklinik@klinikum-fulda.de» Ansprechpartner anzeigen Brustzentrum der Universitätsmedizin Göttingen Robert-Koch-Straße 40 37075 Göttingen DeutschlandNoch nicht rekrutierend » Google-Maps Ansprechpartner: Arne Strauß, Dr. Phone: 055160823 E-Mail: astrauss@med.uni-goettingen.de» Ansprechpartner anzeigen Hämatologisch-Onkologische Praxis Stolberg 52222 Stolberg (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend » Google-Maps Ansprechpartner: Matthias Groschek, MD E-Mail: m.groschek@onkologie-stolberg.de» Ansprechpartner anzeigen Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus 53113 Bonn (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend » Google-Maps Ansprechpartner: Yon-Dschun Ko, Prof. Phone: 0228 5432203 E-Mail: yon-dschun.ko@johanniter-kliniken.de» Ansprechpartner anzeigen Universitätsklinikum Essen (AöR) 45147 Essen (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend » Google-Maps Ansprechpartner: Viktor Grünwald, Prof. Phone: 0201723-2637 E-Mail: viktor.gruenwald@uk-essen.de» Ansprechpartner anzeigen Darmkrebszentrum der Universitätsmedizin Mainz Langenbeckstraße 1 55131 Mainz DeutschlandNoch nicht rekrutierend » Google-Maps Ansprechpartner: Rene Mager, Dr. Phone: 06131172041 E-Mail: rene.mager@unimedizin-mainz.de» Ansprechpartner anzeigen Krankenhaus Barmherzige Brüder Trier 54292 Trier (Rheinland-Pfalz) GermanyRekrutierend » Google-Maps Ansprechpartner: Nina Heidger, Dr. Phone: 06512082401 E-Mail: n.heidger@bk-trier.de» Ansprechpartner anzeigen Universitätsklinikum Magdeburg A.ö.R. 39120 Magdeburg (Sachsen-Anhalt) GermanyRekrutierend » Google-Maps Ansprechpartner: Andreas Janitzky, Dr. Phone: 03916724770 E-Mail: andreas.janitzky@med.ovgu.de» Ansprechpartner anzeigen Urologische Arztpraxis Dr. Ralf Eckert Wittenberg (Sachsen-Anhalt) GermanyNoch nicht rekrutierend » Google-Maps Ansprechpartner: Ralf Eckert, Dr. Phone: 03475250059 E-Mail: urologiestudie.eckert@web.de» Ansprechpartner anzeigen Praxis Dr. Schulze 04416 Markkleeberg (Sachsen) GermanyNoch nicht rekrutierend » Google-Maps Ansprechpartner: Matthias Schulze, Dr. Phone: 03413542755 E-Mail: info@praxis-schulze.de» Ansprechpartner anzeigen Darmkrebszentrum am Universitätsklinikum Schleswig-Holstein, Campus Lübeck Ratzeburger Allee 160 23562 Lübeck DeutschlandRekrutierend » Google-Maps Ansprechpartner: Nils Gilbert, Dr. Phone: 045150043601 E-Mail: Nils.Gilbert@uksh.de» Ansprechpartner anzeigen FEK - Friedrich-Ebert-Krankenhaus Neumünster 24534 Neumünster (Schleswig-Holstein) GermanyNoch nicht rekrutierend » Google-Maps Ansprechpartner: Stefan Mahlmann, Dr. Phone: 043214055037 E-Mail: stefan.mahlmann@fek.de» Ansprechpartner anzeigen Katholisches Krankenhaus St. Johann Nepomuk Erfurt 99097 Erfurt (Thüringen) GermanyAktiv, nicht rekrutierend » Google-Maps Klinikum St. Marien Amberg 92224 Amberg (Bayern) GermanyRekrutierend » Google-Maps Ansprechpartner: Ludwig Fischer von Weikersthal, Dr.med. » Ansprechpartner anzeigen Onkologisches Versorgungszentrum 10407 Berlin (Berlin) GermanyRekrutierend » Google-Maps Ansprechpartner: Fritz Maiwirth, Dr.med. » Ansprechpartner anzeigen Vivantes Klinikum Neukölln 12351 Berlin (Berlin) GermanyRekrutierend » Google-Maps Ansprechpartner: Maike de Wit, Prof. Dr. » Ansprechpartner anzeigen BAG Onkologische Gemeinschaftspraxis 01307 Dresden (Sachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Lutz Jacobasch, Dr.med. » Ansprechpartner anzeigen Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. 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Detailed Description: The goal of our study is to define the benefit of proactive coaching in mRCC, when compared to a reactive approach, which is considered the standard of care. Patients in the Coaching Arm A will be trained continuously at personal interactions of coach and patient (Face-to Face meetings as well as telephone contacts). The patient is educated on nature and severity of treatment emergent Adverse events (TEAE) of sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy. Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and Arm B non Coaching).
Inclusion Criteria: 1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years at time of study entry 3. Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib 4. Intended first-line treatment with sunitinib 5. Documented progressive disease within 6 months prior to study inclusion 6. Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible. 7. Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects. 8. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry. 9. Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.Exclusion Criteria: 1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy) 2. Previous malignancy (other than mRCC) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1]. 3. CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids. 4. Chronic liver disease with Child-Pugh B or C score 5. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year) 6. Any condition that, in the opinion of the investigator, would interfere with evaluation of the concomitant coaching or QoL assessments or interpretation of patient safety or study results 7. Participation in another clinical study with an investigational product during the last 30 days before inclusion 8. Any previous treatment with a tyrosine kinase inhibitor for metastatic disease. Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that relapse occurred at least 6 months after last exposure 9. Previous enrollment or randomization in the present study (does not include screening failure). 10. Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site) 11. Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator 12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG]. 13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
Primary outcome: 1. QoL assessment during sunitinib treatment: questionnaire (Time Frame - 24 weeks from randomization):Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire. Secondary outcome: 1. Objective Response Rate (ORR) according to RECIST 1.1 criteria (Time Frame - up to one year from randomization):Objective Response Rate (ORR) according to RECIST 1.1 criteria 2. Overall Survival (OS) (Time Frame - up to 36 months from randomization):Overall Survival (OS) 3. progression-free survival (PFS) (Time Frame - up to 36 months from randomization):progression-free survival (PFS) 4. Duration of treatment (coaching and cancer treatment) (Time Frame - Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization):Duration of treatment (coaching and cancer treatment) 5. dose density of sunitinib (Time Frame - 24 weeks from randomization):dose density of sunitinib 6. Rate of patients receiving treatment beyond progression (Time Frame - up to 36 months from randomization):Rate of patients receiving treatment beyond progression 7. Further cancer treatment (Time Frame - up to 36 months):Further cancer treatment 8. Time to first subsequent therapy (TFST) (Time Frame - up to 36 months):Time to first subsequent therapy (TFST) 9. Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs): (Time Frame - 24 weeks from randomization):% of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension) 10. Treatment Emergent Adverse Events according to CTC 4.03: (Time Frame - 24 weeks from randomization):Frequency/incidence, severity, percentage reduction, time-to-event of ADRs, AEs and specific TEAEs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)
change of grade 3/4 ADRs 11. Assessment of comorbidities (Time Frame - at inclusion):Charlson Comorbidity Index (CCI)
Experimental: Arm A (Coaching)Concomitant coaching (24 weeks) Pro-active TEAE (Treatment emergent adverse events) management Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15 No Intervention: Arm B (Control)Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15
Concomitant coaching:The corner stones of the pro-active coaching are as follows:
Patient education:
Information on nature and severity of treatment emergent AEs
information about remedies for TEAEs
propagation and explanation of tests and treatment decisions
Patient instruction on self-care and preventive measures
Preemptive AE treatment strategies
Supervision of reported ADR severity, ADR mitigation strategies according to recommendations of the PREPARE protocol and cancer treatment modification by treating physician in close collaboration with the coach
Quelle: ClinicalTrials.gov
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"Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy"
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