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New treatment option for Kidney Cancer
Official title Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial
ClinicalTrials.gov ID: NCT03977571
What this study is testing
- What it's testing
- BACKGROUND: For synchronous metastatic renal cell carcinoma (RCC), surgical resection of the primary tumor in the presence of distant metastases has been the standard of therapy for select patients followed by systemic therapy. In the era of TKIs two randomized trials, CARMENA and SURTIME, have questioned the role and timing of surgery in these patients, results point towards no surgery or a deferred approach.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written informed consent obtained prior to any study specific procedures.
- Patient must be willing and able to comply with the protocol.
- Age ≥18.
- Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.
- Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.
You likely can't join if
- Prior systemic treatment for mRCC
- Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).
- Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
- Clinically significant (i.e active) cardiovascular disease for example cerebrovascular accidents (\< 6 months before inclusion), myocardial...
- No symptomatic brain metastasis requiring systemic corticosteroids (\> 10 mg daily prednisone equivalent)
- Recent (within the 30 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.
See the full eligibility criteria
- Signed written informed consent obtained prior to any study specific procedures.
- Patient must be willing and able to comply with the protocol.
- Age ≥18.
- Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.
- Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.
- Measurable disease as per RECIST v 1.1
- Patients for which Nivolumab/Ipilimumab or a TKI/IO-combination is considered indicated according to the recommendations by the European Medicines Agency and the national health authorities of participating countries...
- Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
- Fertile women of childbearing potential (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in...
- Karnofsky Performance status ≥70
- Life expectancy of greater than 4 months.
- The required laboratory values are as follows:
- Adequate bone marrow function (Leucocytes \> 3.0 x 109/l, platelets \> 100 x 109/l, hemoglobin \> 6.0 mmol/l or \> 10.0 g/dL.)
- International normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN)
- Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALAT ≤ 2.5 x ULN or ≤ 5 x ULN if liver lesions)
- Adequate kidney function (eGFR \> 35 mL/min)
- Prior systemic treatment for mRCC
- Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).
- Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
- Clinically significant (i.e active) cardiovascular disease for example cerebrovascular accidents (\< 6 months before inclusion), myocardial infarction (\< 6 months before inclusion), unstable angina, New York Heart...
- No symptomatic brain metastasis requiring systemic corticosteroids (\> 10 mg daily prednisone equivalent)
- Recent (within the 30 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.
- Any active or recent history of a known or suspected autoimmune disease or recent history of a condition that require systemic corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive...
- Known hypersensitivity to monoclonal antibodies.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection.
- Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Central Region of Denmark, Denmark
- Herlev, Denmark
- Odense, Denmark
- Ålesund, Norway
- Bergen, Norway
- Stavanger, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Central Region of Denmark, Denmark; Herlev, Denmark; Odense, Denmark; Ålesund, Norway; Bergen, Norway; Stavanger, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.