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Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib (PREPARE)

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ClinicalTrials.gov Identifier: NCT03013946
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
Pfizer
Celerion
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Brief Summary:
The primary objective of the trial is to determine the effect of a 24-week concomitant coaching on patient reported outcomes of patients receiving standard treatment for mRCC with sunitinib.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Behavioral: Concomitant coaching Phase 3

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 the Sunitinib-Therapy.

Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and Arm B non Coaching).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sunitinib

Arm Intervention/treatment
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
Behavioral: 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

No Intervention: Arm B (Control)
Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15



Primary Outcome Measures :
  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 Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013946


Contacts
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Contact: Aysun Karatas, Dr. +49 30 8145 344 ext 31 aysun.karatas@aio-studien-ggmbh.de
Contact: Markus Detzner +49 30 8145344 ext 52 Markus.Detzner@aio-studien-ggmbh.de

Locations
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Germany
Klinikum St. Marien Amberg Recruiting
Amberg, Germany, 92224
Contact: Ludwig Fischer von Weikersthal, Dr.med.         
Onkologisches Versorgungszentrum Recruiting
Berlin, Germany, 10407
Contact: Fritz Maiwirth, Dr.med.         
Vivantes Klinikum Neukölln Recruiting
Berlin, Germany, 12351
Contact: Maike de Wit, Prof. Dr.         
BAG Onkologische Gemeinschaftspraxis Recruiting
Dresden, Germany, 01307
Contact: Lutz Jacobasch, Dr.med.         
Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie Not yet recruiting
Dresden, Germany, 01307
Contact: Johannes Mohm, Dr. med.         
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Manfred Wirth, Prof. Dr.         
MVZ für Hämato/Onkologie Essen gGmbH Not yet recruiting
Essen, Germany, 45136
Contact: Ulla Frfr. von Verschuer, Dr.         
MVZ Onkologische Kooperation Harz Recruiting
Goslar, Germany, 38642
Contact: Mark-Oliver Zahn, Dr.         
Onkologische Schwerpunktpraxis Göttingen Not yet recruiting
Göttingen, Germany, 37073
Contact: Michael Metz, Dr.         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Philipp Ivanyi, Dr.    +49 511 532 ext 2301    Ivanyi.Philipp@mh-hannover.de   
Urologie Herzberg Not yet recruiting
Herzberg, Germany, 37412
Contact: Thorsten Werner         
IDGGQ Institut für medizinische Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung Not yet recruiting
Kaiserslautern, Germany, 67655
Contact: Richard Hansen, Dr. med.         
Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin Not yet recruiting
Landshut, Germany, 84028
Contact: Ursula Vehling-Kaiser, Dr. med.         
Gemeinschaftspraxis für Hämatologie u. Onkologie PD Dr. Jan Schröder Not yet recruiting
Mühlheim, Germany, 45468
Contact: Jan Schröder, PD Dr.         
Universitätsklinikum Münster Not yet recruiting
Münster, Germany, 48149
Contact: Martin Bögemann, PD Dr.         
Klinikum Nürnberg 5. Medizinische Klinik Recruiting
Nürnberg, Germany, 90419
Contact: Marinela Augustin, Dr.med.         
Medius KLINIKEN gGmbH Not yet recruiting
Ostfildern, Germany, 73760
Contact: Serdar Deger, Prof. Dr.         
Wissenschaftskontor Nord GmbH & Co KG Recruiting
Rostock, Germany, 18107
Contact: Andreas Hübner, Dr.         
Onkologische Schwerpunktpraxis Recruiting
Singen, Germany, 78224
Contact: Ulrich Banhardt, Dr. med.         
MVZ Kloster Paradiese GbR/Onkologiezentrum Soest Not yet recruiting
Soest, Germany, 59494
Contact: Anke Wortmann, Dr.         
Sponsors and Collaborators
AIO-Studien-gGmbH
Pfizer
Celerion
Investigators
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Principal Investigator: Viktor Grünwald, Prof. Dr. Universitätsklinikum Essen

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Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT03013946     History of Changes
Other Study ID Numbers: AIO-NZK-0115/ass
2016‐000399‐28 ( EudraCT Number )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action