NCT02187042: RENACALL

Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line

Completed Results posted Last updated 24 October 2019

What this trial tests

trial testing Best supportive care in Metastatic/Advanced Renal Cell Carcinoma in 70 participants. Completed in 25 July 2018.

Timeline

7 October 2015

Primary endpoint
25 July 2018

25 July 2018

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	70
Start date	7 October 2015
Primary completion	25 July 2018
Estimated completion	25 July 2018
Sites	13 locations across France

Drugs / interventions tested

• Best supportive care
• call center

Conditions studied

• Metastatic/Advanced Renal Cell Carcinoma — all drugs for Metastatic/Advanced Renal Cell Carcinoma →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Metastatic/Advanced Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Primary · Baseline up to 6 months

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention A

Group	Value	95% CI
Call Center	34
Standard of Care	14

Number of Participants With at Least 1 Sunitinib Dose Reduction Secondary · Baseline up to 6 months

Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.

Group	Value	95% CI
Call Center	12
Standard of Care	4

Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction Secondary · Baseline up to 6 months

Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.

Group	Value	95% CI
Call Center	12
Standard of Care	3
Call Center	0
Standard of Care	1

Average Sunitinib Dose Reduction Secondary · Baseline up to 6 months

Group	Value	95% CI
Call Center	12.5	± 0
Standard of Care	12.5	± 0

Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment Secondary · Baseline up to 6 months

Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.

Group	Value	95% CI
Call Center	27
Standard of Care	8

Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment Secondary · Baseline up to 6 months

Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.

Group	Value	95% CI
Call Center	10.5	± 11.5
Standard of Care	16.6	± 19.4

Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption Secondary · Baseline up to 6 months

Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.

AE

Group	Value	95% CI
Call Center	19
Standard of Care	7

Surgery

Group	Value	95% CI
Call Center	1
Standard of Care	0

Omission

Group	Value	95% CI
Call Center	4
Standard of Care	0

Doctor choice

Group	Value	95% CI
Call Center	6
Standard of Care	1

Other

Group	Value	95% CI
Call Center	2
Standard of Care	1

Number of Participants Who Permanently Discontinued Sunitinib Treatment Secondary · Baseline up to 6 months

Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.

Group	Value	95% CI
Call Center	13
Standard of Care	14

Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation Secondary · Baseline up to 6 months

Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.

Group	Value	95% CI
Call Center	4
Standard of Care	8
Call Center	6
Standard of Care	5
Call Center	1
Standard of Care	0
Call Center	1
Standard of Care	0

Mean Duration of Sunitinib Treatment Secondary · Baseline up to 6 months

Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.

Group	Value	95% CI
Call Center	4.8	± 1.9
Standard of Care	4.2	± 1.9

Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles Secondary · Baseline up to 6 months

Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped

Group	Value	95% CI
Call Center	6
Standard of Care	3
Call Center	1
Standard of Care	7
Call Center	7
Standard of Care	5
Call Center	28
Standard of Care	12

Number of Participants With At Least 1 Unplanned Hospitalization Secondary · Baseline up to 6 months

Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.

Group	Value	95% CI
Call Center	9

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 6 months. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Call Center

Serious: 12/42 (29%)

Deaths: 2/42

Standard of Care

Serious: 15/27 (56%)

Deaths: 3/27

Serious adverse events (37 terms)

Reaction	System	Call Center	Standard of Care
Anaemia	Blood and lymphatic system disorders	—	—
Hypertension	Vascular disorders	—	—
Pyrexia	General disorders	—	—
Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cerebrovascular Accident	Nervous system disorders	—	—
Haematuria	Renal and urinary disorders	—	—
Renal Failure	Renal and urinary disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Cardiac Failure	Cardiac disorders	—	—
Adrenal Insufficiency	Endocrine disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Death	General disorders	—	—
General Physical Health Deterioration	General disorders	—	—
General Symptom	General disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—
Infection	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Pyelonephritis	Infections and infestations	—	—
Anti-Platelet Antibody Positive	Investigations	—	—
Weight Decreased	Investigations	—	—
Gout	Metabolism and nutrition disorders	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Aphasia	Nervous system disorders	—	—

Other adverse events (132 terms — click to expand)

Reaction	System	Call Center	Standard of Care
Hypertension	Vascular disorders	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—
Dysgeusia	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Mucosal Inflammation	General disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Weight Decreased	Injury, poisoning and procedural complications	—	—
Headache	Nervous system disorders	—	—
Gingivitis	Gastrointestinal disorders	—	—
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Aphthous Ulcer	Gastrointestinal disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Yellow Skin	Skin and subcutaneous tissue disorders	—	—
Dry Mouth	Gastrointestinal disorders	—	—
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	—	—
Dry Skin	Skin and subcutaneous tissue disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Skin Discolouration	Skin and subcutaneous tissue disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Pain	General disorders	—	—
Chills	General disorders	—	—
Pyrexia	General disorders	—	—
Blood Thyroid Stimulating Hormone Increased	Injury, poisoning and procedural complications	—	—
Pain In Extremity	Musculoskeletal and connective tissue disorders	—	—
Skin Irritation	Skin and subcutaneous tissue disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Abdominal Distension	Gastrointestinal disorders	—	—
Glossitis	Gastrointestinal disorders	—	—
Oedema Peripheral	General disorders	—	—

Most-reported serious reactions: Anaemia, Hypertension, Pyrexia, Neoplasm Progression, Cerebrovascular Accident, Haematuria, Renal Failure, Thrombocytopenia.

Data from ClinicalTrials.gov NCT02187042 adverse events section.

Sponsor's own description

100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center

Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.