Observational Study Evaluating The Efficacy And Effects On Quality Of Life Of Targeted Treatments Following TKIs In mRCC

NCT02315755 | Completed Results

• 1 other identifier: A4061086
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 19

Brief Summary

Metastatic renal cell carcinoma (mRCC) is the most common malignant tumour of the kidneys. Targeted therapies, which were recently introduced in the treatment of mRCC, have become the standard treatment in these patients. With improved survival rate and a tolerable side effect profile, Tyrosine Kinase Inhibitors (TKIs) have largely replaced conventional immunotherapies worldwide. In Turkey, due to reimbursement conditions, cytokine (interferon alpha) treatment is the standard treatment as first-line therapy. Therefore, the data on quality of life (QoL) from the pivotal studies with standard TKI treatment does not reflect the QoL status of patients treated with TKIs as second or third line treatment in Turkey. In this study, the clinical outcomes and the impact on quality of life of targeted treatments following TKIs will be explored. To our knowledge, since there is no similar reimbursement condition in the world placing IFN as the first line standard treatment, this will be the first study evaluating the QoL status with targeted therapies used as 3rd line treatment in mRCC patients.

Conditions

Renal Cell Carcinoma

Keywords

Metastatic renal cell carcinoma, targeted molecular therapy

Outcome Measures

Primary Outcomes (17)

• Progression Free Survival (PFS)

  PFS was defined as the time duration (in months) during and after the treatment of disease that a participant lived with the disease but it did not get worse or progressed. Progressive disease as per response evaluation criteria in solid tumors (RECIST) version 1.1 defined as at least a 20 percent (%) increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 millimeter (mm) in addition to the relative increase of 20%.

  From the start of disease treatment until disease progression or death due to any cause (up to a maximum of 33 months)

• Percentage of Participants With Overall Objective Response

  Overall objective response was defined as the percentage of participants with best confirmed response (partial response \[PR\], stable disease \[SD\] or progressive disease \[PD\]) recorded from the start of the study treatment until the end of treatment as assessed by RECIST version 1.1. PR defined as a 30% or more decrease in the sum of longest dimensions of the target lesions, taking as reference the baseline sum of longest dimensions. PD defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference to the smallest sum diameters while on study.

  Baseline until the maximum of 33 months

• Functional Assessment of Cancer Therapy Kidney Symptom Index - 15 (FKSI-15) Score at Baseline

  FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.

  Baseline (Day 1 of Month 1)

• Change From Baseline in FKSI-15 Score at Month 3

  FKSI was used to assess QoL of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.

  Baseline (Day 1 of Month 1), Month 3

• Change From Baseline in FKSI-15 Score at Month 6

  FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.

  Baseline (Day 1 of Month 1), Month 6

• Change From Baseline in FKSI-15 Score at Month 9

  FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.

  Baseline (Day 1 of Month 1), Month 9

• Change From Baseline in FKSI-15 Score at Last Follow-up

  FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.

  Baseline (Day 1 of Month 1), last follow-up visit (up to 33 months)

• EuroQol-5 Dimension-3 Level (EQ5D-3L) Scores at Baseline

  EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best).

  Baseline (Day 1 of Month 1)

• Change From Baseline in EQ5D-3L Scores at Month 3

  EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.

  Baseline (Day 1 of Month 1), Month 3

• Change From Baseline in EQ5D-3L Score at Month 6

  EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.

  Baseline (Day 1 of Month 1), Month 6

• Change From Baseline in EQ5D-3L Score at Month 9

  EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.

  Baseline (Day 1 of Month 1), Month 9

• Change From Baseline in EQ5D-3L Score at Last Follow-up

  EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.

  Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)

• Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) Score at Baseline

  FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.

  Baseline (Day 1 of Month 1)

• Change From Baseline in FKSI-DRS Score at Month 3

  FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.

  Baseline (Day 1 of Month 1), Month 3

• Change From Baseline in FKSI-DRS Score at Month 6

  FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.

  Baseline (Day 1 of Month 1), Month 6

• Change From Baseline in FKSI-DRS Score at Month 9

  FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.

  Baseline (Day 1 of Month 1), Month 9

• Change From Baseline in FKSI-DRS Score at Last Follow-up

  FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.

  Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)

Secondary Outcomes (9)

• Overall Survival

  From the start of 3rd line treatment until death due to any cause (up to a maximum of 33 months)

• Overall Survival at Year 1: Percentage of Participants Who Survived at Year 1

  Baseline until death due to any cause (up to 1 year)

• Time to Treatment Failure

  Baseline until disease progression or discontinuation, due to any cause (up to 33 months)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 12 months

• Number of Participants With Grade 3 or Higher Severe Adverse Events (AEs) Based on NCI CTCAE Version 4.03

  Baseline up to 12 months

Study Arms (1)

Study cohort

Metastatic renal cell carcinoma patients under 3rd line targeted therapy following 1st line interferon alpha and 2nd line TKI. All patients will be ≥ 18 years old and have signed the informed consent document.

Eligibility Criteria

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

Study Population

Metastatic renal cell carcinoma patients under 3rd line targeted therapy following 1st line interferon alpha and 2nd line TKI. All patients will be ≥ 18 years old and have signed the informed consent document.

You may qualify if:

• Histologically confirmed metastatic renal cell cancer patients who have already been using targeted therapies for up to 3 months as 3rd line treatment
• Patients older than 18 years
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study.

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• Patients with contraindications for the use of the study medications
• Patients with (suspected) pregnancy or in lactation period
• Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
• Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before included in the current study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Gazi University

Ankara, Besevler, 06500, Turkey (Türkiye)

Location

Abdurrahman Yurtaslan Onkoloji Hastanesi

Ankara, Demetevler, 06200, Turkey (Türkiye)

Location

Marmara Üniversitesi Pendik Eğtim Araştırma Hastanesi

Pendik, İ̇stanbul, 34899, Turkey (Türkiye)

Location

Hacettepe University School of Medicine, Department of Medical Oncology

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Numune Egitim Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi

Bornova/Izmir, 35100, Turkey (Türkiye)

Location

Ali Osman Sonmez Onkoloji Hastanesi

Bursa, Turkey (Türkiye)

Location

Dicle Universitesi Tip Fakultesi

Diyarbakır, 21080, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali Tibbi Onkoloji Bilim Dal

Edirne, Turkey (Türkiye)

Location

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi Onkoloji Enstitusu

Istanbul, 34390, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, 35340, Turkey (Türkiye)

Location

Izmir Katip Celebi Universitesi Ataturk Egitim Arastirma Hastanesi Medikal Onkoloji Departmani

Izmir, 35360, Turkey (Türkiye)

Location

Dr Lufti Kirdar Kartal Egitim ve Arastirma Hastanesi

Kartal, Turkey (Türkiye)

Location

Konya Necmettin Erbakan Universitesi Meram Tip Fakultesi Tibbi Onkoloji Anabilim Dali

Konya, Turkey (Türkiye)

Location

Inonu Universitesi Tip Fakultesi Medikal Onkoloji Bilim Dali

Malatya, Turkey (Türkiye)

Location

Gaziantep Universitesi Tip Fakultesi

Sehitkamil/Gaziantep, 27310, Turkey (Türkiye)

Location

Erciyes Universitesi Tip Fakultesi

Talas / Kayseri, 38039, Turkey (Türkiye)

Location

Karadeniz Teknik Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

Trabzon, Turkey (Türkiye)

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: May 11, 2015
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (19)