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Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma (SURF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02689167
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off "

As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1:

  • Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off "
  • Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "

Condition or disease Intervention/treatment Phase
Kidney Neoplasms Metastatic Renal Cell Cancer Drug: Sunitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Randomised Multi-centre Phase II Study to Assess the Efficacy and Tolerability of Sunitinib by Dose Administration Regimen (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma
Actual Study Start Date : February 19, 2016
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : February 2024


Arm Intervention/treatment
Active Comparator: Arm A 4/6
Sunitinib 37.5 mg/day; regimen 4/6 (Marketing Authorisation Indication) 4 weeks "on " alternating with 2 weeks "off "
Drug: Sunitinib
Experimental: Arm B 2/3
Sunitinib 50 mg/day; regimen 2/3 (experimental arm) 2 weeks "on " alternating with 1 week "off "
Drug: Sunitinib



Primary Outcome Measures :
  1. MDT (median duration of treatment) [ Time Frame: 12 mo ]
    The primary objective of this study is to estimate the median duration of treatment in each treatment group (arm A vs arm B) calculated from sunitinib initiation.


Secondary Outcome Measures :
  1. PFS (progression-free survival) [ Time Frame: 12 months ]
    To estimate progression-free survival in patients included in each of the groups and in the overall population included in this study.

  2. OS (overall survival) [ Time Frame: 30 months ]
    To estimate overall survival in patients included in each of the groups and in the overall population included in this study.

  3. duration of sunitinib post randomization [ Time Frame: 12 months ]
    Estimation of the time between date of randomization and sunitinib arrest (for any reason) in the two treatment arms.

  4. time to randomization [ Time Frame: 4 months ]
    To estimate the time to randomization defined as the time between the date of sunitinib initiation and the date of randomization.

  5. ORR (objective response rate) [ Time Frame: 6 months ]
    To measure the objective response rate according to RECIST 1.1 criteria.

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 months ]
    To assess safety profile before and after randomization.

  7. QOL (quality of life) [ Time Frame: 24 months ]
    To assess health-related quality of life since sunitinib is started (before randomization, at the time of randomization and after randomization)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Men or women over 18 years old
  • Patients with local, advanced or inoperable or metastatic (MRCC) renal cell carcinoma who are starting first line treatment with Sunitinib 50mg (4/6 regimen) according to the Marketing Authorisation Indication
  • Patients with histologically or cytologically confirmed renal cancer, clear cell variant or with a clear cell component
  • Karnofsky performance status ≥ 70%
  • Adequate organ function:

    • Absolute neutrophil (N) count ≥ 1 500 / µL
    • Platelets ≥ 100 000 / µL
    • Haemoglobin ≥ 10 g/dL
    • Adjusted serum calcium ≤ 2.6 mmol/L
    • Creatinine clearance ≥ 30 mL/min (by the MDRD formula)
    • Total bilirubin ≤ 1.5 x ULN (upper limit of the normal range)
    • AST ≤ 2.5 x ULN and ALT ≤ 2.5 x ULN OR AST and ALT ≤ 5 x ULN if liver abnormalities due to liver metastases AST = aspartate aminotransferase ALT = alanine aminotransferase

Key Exclusion Criteria:

  • Renal carcinoma with no clear cell component.
  • Previous systemic treatment for the RCC regardless of type (including targeted therapy, immunotherapy, chemotherapy, hormone or experimental therapy). Previous or concomitant treatment with a bisphosphonate or denosumab is allowed.
  • Patients whose clinical state and comorbidities are not consistent with administration of Sunitinib at the initial dose of 50mg/day 4 weeks out of 6.
  • Grade 3 haemorrhage within 4 weeks before starting treatment with Sunitinib (according to the NCI-CTCAE toxicity score version 3.0).
  • The presence of a past history of cancer in the 3 years before inclusion into the study
  • Major surgery within 4 weeks before sunitinib initiation
  • Past history of symptomatic cerebral metastases, spinal cord compression or meningeal carcinomatosis. Patients with cerebral metastases discovered incidentally on imaging and who are asymptomatic are not excluded if these metastases have been treated (radiotherapy and/or surgery) with a period of at least 4 weeks between the end of treatment and inclusion into the study and no clinical or radiological signs of relapse, and corticosteroid dose is not exceeding 10mg/day of prednisone or equivalent. Subjects will be excluded if subjects have signs of grade ≥ 2 treatment-related complications.
  • Any of the following features within 6 months of the administration of Sunitinib: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
  • Pulmonary embolism or deep vein thrombosis within 3 months of inclusion (unless it's stable, asymptomatic and treated with a low molecular weight heparin for at least 6 weeks before inclusion).
  • Any known acute or chronic disorder (such as severe chronic obstructive pulmonary disease) which in the opinion of the investigator could impact on the patient's capacity to receive the study treatment or make interpretation of toxicity or adverse events difficult.
  • Known HIV infection.
  • History of chronic active hepatitis including subjects who are carriers of the hepatitis B (HBV) or hepatitis C (HCV) virus.
  • Existence of uncontrolled infection.
  • Uncontrolled hypertension defined as a blood pressure of > 150 mmHg systolic or > 100 mmHg diastolic despite optimal anti-hypertensive therapy (blood pressure must be controlled at inclusion).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689167


Contacts
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Contact: Elise Robert e1robert@chu-besancon.fr

Locations
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France
CHU Besancon Recruiting
Besancon, Franche-Comté, France, 25030
Contact: Elise Robert       e1robert@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Pfizer
Investigators
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Principal Investigator: antoine thiery-vuillemin, MD PhD Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02689167    
Other Study ID Numbers: P/2015/254
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
renal cell carcinoma
sunitinib
metastatic
schedule
toxicity
safety
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action