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

NCT03013946 | Terminated Phase 3

• 2 other identifiers: AIO-NZK-0115/ass2016-000399-28
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 22

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 or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.

Conditions

Renal Cell Carcinoma, Metastatic; Renal Cell Cancer, Recurrent

Keywords

Therapy-Coaching, Quality of Life

Outcome Measures

Primary Outcomes (1)

• QoL assessment during sunitinib treatment: questionnaire

  Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.

  24 weeks from randomization

Secondary Outcomes (11)

• Objective Response Rate (ORR) according to RECIST 1.1 criteria

  up to one year from randomization

• Overall Survival (OS)

  up to 36 months from randomization

• progression-free survival (PFS)

  up to 36 months from randomization

• Duration of treatment (coaching and cancer treatment)

  Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization

• dose density of sunitinib

  24 weeks from randomization

Study Arms (2)

Arm A (Coaching)

EXPERIMENTAL

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

Arm B (Control)

NO INTERVENTION

Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

Interventions

Concomitant coaching BEHAVIORAL

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

Arm A (Coaching)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥ 18 years at time of study entry
• 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
• Intended first-line treatment with sunitinib
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
• 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 \[Ta, Tis and T1\].
• CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
• Chronic liver disease with Child-Pugh B or C score
• 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)
• 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
• 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
• Previous enrollment or randomization in the present study (does not include screening failure).
• Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
• Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
• Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities \[§ 40 Abs. 1 S. 3 Nr. 4 AMG\].
• 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 \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\].

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Pfizer: collaborator
• Crolll Gmbh: collaborator

Study Sites (22)

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, Bavaria, 93049, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Universitätsklinikum Essen (AöR)

Essen, Nordrhein-Westphalen, 45147, Germany

Location

Hämatologisch-Onkologische Praxis Stolberg

Stolberg, North Rhine-Westphalia, 52222, Germany

Location

Krankenhaus Barmherzige Brüder Trier

Trier, Rhineland-Palatinate, 54292, Germany

Location

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Urologische Arztpraxis Dr. Ralf Eckert

Wittenberg, Saxony-Anhalt, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Klinikum St. Marien Amberg

Amberg, 92224, Germany

Location

Onkologisches Versorgungszentrum

Berlin, 10407, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

BAG Onkologische Gemeinschaftspraxis

Dresden, 01307, Germany

Location

Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie

Dresden, 01307, Germany

Location

MVZ für Hämato/Onkologie Essen gGmbH

Essen, 45136, Germany

Location

MVZ Onkologische Kooperation Harz

Goslar, 38642, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin

Landshut, 84028, Germany

Location

Klinikum Nürnberg 5. Medizinische Klinik

Nuremberg, 90419, Germany

Location

Wissenschaftskontor Nord GmbH & Co KG

Rostock, 18107, Germany

Location

Onkologische Schwerpunktpraxis

Singen, 78224, Germany

Location

MVZ Kloster Paradiese GbR/Onkologiezentrum Soest

Soest, 59494, Germany

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Viktor Grünwald, Prof. Dr.

  Universitätsklinikum Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 9, 2017
• Study Start: January 18, 2017
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (22)