Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib
NCT03013946
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
+49 30 8145 344
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.
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].
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Descriptive Information | |||||||||
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Brief Title ICMJE | Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib | ||||||||
Official Title ICMJE | A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib | ||||||||
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. | ||||||||
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). | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care | ||||||||
Condition ICMJE |
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Intervention ICMJE | Behavioral: Concomitant coaching
The corner stones of the pro-active coaching are as follows:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 430 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 2023 | ||||||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Germany | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03013946 | ||||||||
Other Study ID Numbers ICMJE | AIO-NZK-0115/ass 2016-000399-28 ( EudraCT Number ) | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | AIO-Studien-gGmbH | ||||||||
Study Sponsor ICMJE | AIO-Studien-gGmbH | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | AIO-Studien-gGmbH | ||||||||
Verification Date | January 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |