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Kidney NeoplasmsPhase 2SURFNCT02689167

Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma

A Phase 2 study testing Sunitinib in people with Kidney Neoplasms and Metastatic Renal Cell Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteFrance
Study dates
19 Feb 2016to Feb 2024
Phase
Phase 2
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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Besancon

    Besançon, Franche-Comté, 25030

Other trials in France

About this study

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

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 "
Being tested
Sunitinib
Keywords
renal cell carcinoma, sunitinib, metastatic, schedule, toxicity, safety
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

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

Study groups in NCT02689167
Study groupRoleWhat they receive
Arm A 4/6Active comparatorSunitinib 37.5 mg/day; regimen 4/6 (Marketing Authorisation Indication) 4 weeks "on " alternating with 2 weeks "off "
Receives: Drug: Sunitinib
Arm B 2/3ExperimentalSunitinib 50 mg/day; regimen 2/3 (experimental arm) 2 weeks "on " alternating with 1 week "off "
Receives: Drug: Sunitinib

What is being measured

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

  1. MDT (median duration of treatment)

    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.

    Measured: 12 mo

Secondary outcomes (7)

  1. PFS (progression-free survival)

    To estimate progression-free survival in patients included in each of the groups and in the overall population included in this study.

    Measured: 12 months

  2. OS (overall survival)

    To estimate overall survival in patients included in each of the groups and in the overall population included in this study.

    Measured: 30 months

  3. duration of sunitinib post randomization

    Estimation of the time between date of randomization and sunitinib arrest (for any reason) in the two treatment arms.

    Measured: 12 months

  4. time to randomization

    To estimate the time to randomization defined as the time between the date of sunitinib initiation and the date of randomization.

    Measured: 4 months

  5. ORR (objective response rate)

    To measure the objective response rate according to RECIST 1.1 criteria.

    Measured: 6 months

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    To assess safety profile before and after randomization.

    Measured: 24 months

  7. QOL (quality of life)

    To assess health-related quality of life since sunitinib is started (before randomization, at the time of randomization and after randomization)

    Measured: 24 months

Timeline

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

  1. First posted23 Feb 2016 (estimated)
  2. Study start19 Feb 2016
  3. Primary completionFeb 2024 (estimated)
  4. Study completionFeb 2024 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689167
Sponsor's protocol ID
P/2015/254
Acronym
SURF
Status last verified
Nov 2021
First submitted
10 Feb 2016
Last updated
29 Nov 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mouillet G, Paillard MJ, Maurina T, Vernerey D, Nguyen Tan Hon T, Almotlak H, Stein U, Calcagno F, Berthod D, Robert E, Meurisse A, Thiery-Vuillemin A. Open-label, randomized multicentre 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: study protocol of the SURF trial. Trials. 2018 Apr 12;19(1):221. doi: 10.1186/s13063-018-2613-8.

    PubMed 29650037

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Kidney Neoplasms and Metastatic Renal Cell Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

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 12 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: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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?

MDT (median duration of treatment) (time frame: 12 mo). 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 NCT02689167, which also lists 1 linked publication.

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 29 Nov 2021.

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