A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib

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A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib

Condition: Renal Cell Carcinoma, Metastatic, Renal Cell Cancer, Recurrent

Intervention:

  • Behavioral: Concomitant coaching

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03013946

Sponsor: AIO-Studien-gGmbH

Primary Outcome Measures:

  • Measure: QoL assessment during sunitinib treatment: questionnaire
  • Time Frame: 24 weeks from randomization
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective Response Rate (ORR) according to RECIST 1.1 criteria
  • Time Frame: up to one year from randomization
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: up to 36 months from randomization
  • Safety Issue:
  • Measure: progression-free survival (PFS)
  • Time Frame: up to 36 months from randomization
  • Safety Issue:
  • Measure: Duration of treatment (coaching and cancer treatment)
  • Time Frame: Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization
  • Safety Issue:
  • Measure: dose density of sunitinib
  • Time Frame: 24 weeks from randomization
  • Safety Issue:
  • Measure: Rate of patients receiving treatment beyond progression
  • Time Frame: up to 36 months from randomization
  • Safety Issue:
  • Measure: Further cancer treatment
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Time to first subsequent therapy (TFST)
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):
  • Time Frame: 24 weeks from randomization
  • Safety Issue:
  • Measure: Treatment Emergent Adverse Events according to CTC 4.03:
  • Time Frame: 24 weeks from randomization
  • Safety Issue:
  • Measure: Assessment of comorbidities
  • Time Frame: at inclusion
  • Safety Issue:

Estimated Enrollment: 430

Study Start Date: January 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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].

Contact:

  • Aysun Karatas, Dr.
  • +49 30 8145 344 Ext. 31

Locations:

  • Klinikum St. Marien Amberg
  • Amberg 92224 Germany
  • Onkologisches Versorgungszentrum
  • Berlin 10407 Germany
  • Vivantes Klinikum Neukölln
  • Berlin 12351 Germany
  • BAG Onkologische Gemeinschaftspraxis
  • Dresden 01307 Germany
  • Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie
  • Dresden 01307 Germany
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Dresden 01307 Germany
  • MVZ für Hämato/Onkologie Essen gGmbH
  • Essen 45136 Germany
  • MVZ Onkologische Kooperation Harz
  • Goslar 38642 Germany
  • Onkologische Schwerpunktpraxis Göttingen
  • Göttingen 37073 Germany
  • Medizinische Hochschule Hannover
  • Hannover 30625 Germany
  • Urologie Herzberg
  • Herzberg 37412 Germany
  • IDGGQ Institut für medizinische Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung
  • Kaiserslautern 67655 Germany
  • Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin
  • Landshut 84028 Germany
  • Gemeinschaftspraxis für Hämatologie u. Onkologie PD Dr. Jan Schröder
  • Mühlheim 45468 Germany
  • Universitätsklinikum Münster
  • Münster 48149 Germany
  • Klinikum Nürnberg 5. Medizinische Klinik
  • Nürnberg 90419 Germany
  • Medius KLINIKEN gGmbH
  • Ostfildern 73760 Germany
  • Wissenschaftskontor Nord GmbH & Co KG
  • Rostock 18107 Germany
  • Onkologische Schwerpunktpraxis
  • Singen 78224 Germany
  • MVZ Kloster Paradiese GbR/Onkologiezentrum Soest
  • Soest 59494 Germany

View trial on ClinicalTrials.gov

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