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AzTrials

Renal Cell Carcinoma, MetastaticPhase 3PREPARENCT03013946

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

A Phase 3 study testing Concomitant coaching in people with Renal Cell Carcinoma, Metastatic and Renal Cell Cancer, Recurrent, run by AIO-Studien-gGmbH at 22 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Concomitant coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
22 sitesGermany
Study dates
18 Jan 2017to 16 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Documented progressive disease within 6 months prior to study inclusion
  • 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.
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  • 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.

Who cannot join

  • 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)
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  • 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
  • Participation in another clinical study with an investigational product during the last 30 days before inclusion
  • 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].

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Germany22 sites

  • Klinikum St. Marien Amberg

    Amberg, 92224

  • Onkologisches Versorgungszentrum

    Berlin, 10407

  • Vivantes Klinikum Neukölln

    Berlin, 12351

  • BAG Onkologische Gemeinschaftspraxis

    Dresden, 01307

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

    Dresden, 01307

  • Universitätsklinikum Essen (AöR)

    Essen, Nordrhein-Westphalen, 45147

  • MVZ für Hämato/Onkologie Essen gGmbH

    Essen, 45136

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

  • MVZ Onkologische Kooperation Harz

    Goslar, 38642

  • Universitätsmedizin Göttingen

    Göttingen, Lower Saxony, 37075

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin

    Landshut, 84028

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23562

  • Universitätsklinikum Magdeburg A.ö.R.

    Magdeburg, Saxony-Anhalt, 39120

  • Klinikum Nürnberg 5. Medizinische Klinik

    Nuremberg, 90419

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg, Bavaria, 93049

  • Wissenschaftskontor Nord GmbH & Co KG

    Rostock, 18107

  • Onkologische Schwerpunktpraxis

    Singen, 78224

  • MVZ Kloster Paradiese GbR/Onkologiezentrum Soest

    Soest, 59494

  • Hämatologisch-Onkologische Praxis Stolberg

    Stolberg, North Rhine-Westphalia, 52222

  • Krankenhaus Barmherzige Brüder Trier

    Trier, Rhineland-Palatinate, 54292

  • Urologische Arztpraxis Dr. Ralf Eckert

    Wittenberg, Saxony-Anhalt

Other trials in Germany

About this study

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 or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy

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.

Read the 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).

Being tested
Concomitant coaching
Keywords
Therapy-Coaching, Quality of Life
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concomitant coachingBehavioural

    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
Study groups in NCT03013946
Study groupRoleWhat they receive
Arm A (Coaching)ExperimentalConcomitant 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
Receives: Behavioral: Concomitant coaching
Arm B (Control)No interventionRe-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 weeks from randomization

Secondary outcomes (11)

  1. Objective Response Rate (ORR) according to RECIST 1.1 criteria

    Objective Response Rate (ORR) according to RECIST 1.1 criteria

    Measured: up to one year from randomization

  2. Overall Survival (OS)

    Overall Survival (OS)

    Measured: up to 36 months from randomization

  3. progression-free survival (PFS)

    progression-free survival (PFS)

    Measured: up to 36 months from randomization

  4. Duration of treatment (coaching and cancer treatment)

    Duration of treatment (coaching and cancer treatment)

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

  5. dose density of sunitinib

    dose density of sunitinib

    Measured: 24 weeks from randomization

  6. Rate of patients receiving treatment beyond progression

    Rate of patients receiving treatment beyond progression

    Measured: up to 36 months from randomization

  7. Further cancer treatment

    Further cancer treatment

    Measured: up to 36 months

  8. Time to first subsequent therapy (TFST)

    Time to first subsequent therapy (TFST)

    Measured: up to 36 months

  9. Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):

    % of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)

    Measured: 24 weeks from randomization

  10. Treatment Emergent Adverse Events according to CTC 4.03:

    • 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

    Measured: 24 weeks from randomization

  11. Assessment of comorbidities

    Charlson Comorbidity Index (CCI)

    Measured: at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2017 (estimated)
  2. Study start18 Jan 2017
  3. Primary completion16 Jan 2024
  4. Study completion16 Jan 2024

Why it stopped: insufficient accrual rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013946
Sponsor's protocol ID
AIO-NZK-0115/ass
Other IDs
2016-000399-28, 2016
Acronym
PREPARE
Status last verified
Feb 2025
First submitted
14 Dec 2016
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Concomitant coaching in people with Renal Cell Carcinoma, Metastatic and Renal Cell Cancer, Recurrent, run by AIO-Studien-gGmbH at 22 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: insufficient accrual rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QoL assessment during sunitinib treatment: questionnaire (time frame: 24 weeks from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03013946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

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