Clear-cell Renal CarcinomaPhase 2NEORADNCT01715935
Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus
A Phase 2 study testing Everolimus in people with Clear-cell Renal Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 10 sites in France.
Trial summary
Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma An open-label, exploratory, single-arm, multicenter trial. Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear-cell Renal Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesFrance
- Study dates
- Jun 2012to Apr 2016
- 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
- Advanced RCC or a resectable renal tumor and at least one measurable inoperable metastasis (at least 1 cm), in whom anti-angiogenic therapy is indicated
- Patients without target lesions, with bone metastasis
- Histologically confirmed clear cells RCC and possibility of adequate tumor sampling prior to treatment
- No prior systemic treatment for RCC
- Male or female, at least 18 years
- PS ECOG 0-1
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- Life expectancy at least 3 months
- Adequate organ function with the following criteria:
- Total serum bilirubin equal or less than 2 x ULN (Gilbert's disease exempted)
- Serum transaminases and alkaline phosphatases equal or less than 2.5 x ULN, or in case of liver or bone metastasis equal or less than 5x ULN
- Serum creatinine equal or less than 2 x ULN, creatinine clearance at least 50 ml/min
- Absolute neutrophil count (ANC) at least 1500/mm3
- Platelets at least 100,000/mm3
- Hemoglobin at least 10.0 g/dL
- INR equal or less than 1.7 or prothrombin time (PT) equal or less than 6 sec
- Blood glucose less than 1.5x ULN
- Fasting cholesterol equal or less than 5 mmol/L, triglycerides equal or less than 200 mg/dl,
- Negative pregnancy test within 7 days prior to enrollment
- Signed and dated IRB/ICE-approved informed consent form
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Patient covered by the national health system
Who cannot join
- Previous nephrectomy
- Histology: any histologic type different than ccRCC
- Treatment in a clinical trial in the last 30 days
- Previous treatment with everolimus or other mTOR-inhibitors and anti-angiogenic drugs
- Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack, abnormal lung function.
- Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical treatment
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- Abnormal ECG (Clinically significant)
- Treatment with vitamin K antagonists. Ongoing treatment with therapeutic doses of coumarin derivative anticoagulants (e.g. warfarin) or treatment within the 2 weeks before the first day of everolimus administration. Prophylaxis with low dose warfarin for deep vein thrombosis is permitted (up to 2 mg/day). Low molecular weight heparin is allowed.
- Brain metastasis. (Brain scan or MRI is mandatory). Note: Previous treated brain metastasis (surgery ± radiotherapy, radiotherapy, radiosurgery or gammaknife) and satisfying the following three criteria are allowed:
- Asymptomatic;
- No evidence of any active brain metastasis 3 months prior inclusion;
- No necessity of corticoid or antiepileptic treatment.
- Pregnancy or breastfeeding.
- Any second malignancy within the last 3 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months.
- Clinically significant gastrointestinal abnormalities including but not limited to:
- Malabsorption syndrome
- Major resection of the stomach or small bowel that could affect the absorption of the study drug
- Active peptic ulcer disease
- Inflammatory bowel disease
- Ulcerative colitis or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
- Hepatitis B/C
- Hypersensitivity to everolimus or any excipient of everolimus.
- Any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHRU Besançon
Besançon, 25000
Hôpital Henri Mondor
Créteil, 94000
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85925 cedex 9
Hôpital Saint Eloi - CHU Montpellier
Montpellier, 34285 cedex 5
Fôpital d'Instruction des Amées du Val de Grâce
Paris, 75005
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou - Service d'oncologie médicale
Paris, 7505
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805 cedex
About this study
Official title: A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma
An open-label, exploratory, single-arm, multicenter trial.
Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy.
Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.
Read the detailed description
An open-label, exploratory, single-arm, multicenter trial. Treatment with everolimus will be initiated once patients have undergone baseline screening and provided their written informed consent.
Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to surgery. The starting dose will be 10 mg daily with provision for dose reduction based on tolerability.
Radical nephrectomy will be performed at the end of week 7. For metastatic patients, two to four weeks after surgery, everolimus will be reintroduced. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.
Patients with locally advanced renal carcinoma will stop drug intake before nephrectomy.
Resumption of everolimus may be postponed in cases of a delay in wound healing or surgical complications.
After treatment discontinuation and the last treatment visit (28-days after the last dose), patients will be followed up in order to collect data on the onset of progression and survival. In metastatic patients discontinuing treatment for reasons other than disease progression, tumor assessment will continue every 3 months, until disease progression or initiation of other anticancer therapy for up to one year of follow-up.
- Being tested
- Everolimus
- Keywords
- Clear cells renal carcinoma, everolimus, neo-adjuvant treatment
- Medical subject headings
- Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called AFINITOR
everolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only)
| Study group | Role | What they receive |
|---|---|---|
| everolimus | Experimental | everolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only) Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective clinical benefit
Objective clinical benefit is defined as complete response, partial response or stable disease according to RECIST criteria version 1.1
Measured: After 6 weeks of treatment
Secondary outcomes (3)
Progression Free Survival
Measured: up to 1 year
Overall survival
Measured: up to 2 years
Safety and tolerability
Toxicity will be classify according to NCI-CTC criteria Version 4.0
Measured: Participants will be followed all along the treatment period, an expected average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear-cell Renal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Oudard, MD, PhD, Principal investigator, Hôpital Européen Georges Pompidou, Paris (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715935
- Sponsor's protocol ID
- 2011-000882-11
- Acronym
- NEORAD
- Status last verified
- Feb 2016
- First submitted
- 12 Sep 2012
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01715935
- Acronym / sponsor ID
- NEORAD / 2011-000882-11
- Keywords
- Clear cells renal carcinoma, everolimus, neo-adjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en CancérologieUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma
An open-label, exploratory, single-arm, multicenter trial.
Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy.
Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.
Detailed description
An open-label, exploratory, single-arm, multicenter trial. Treatment with everolimus will be initiated once patients have undergone baseline screening and provided their written informed consent.
Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to surgery. The starting dose will be 10 mg daily with provision for dose reduction based on tolerability.
Radical nephrectomy will be performed at the end of week 7. For metastatic patients, two to four weeks after surgery, everolimus will be reintroduced. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.
Patients with locally advanced renal carcinoma will stop drug intake before nephrectomy.
Resumption of everolimus may be postponed in cases of a delay in wound healing or surgical complications.
After treatment discontinuation and the last treatment visit (28-days after the last dose), patients will be followed up in order to collect data on the onset of progression and survival. In metastatic patients discontinuing treatment for reasons other than disease progression, tumor assessment will continue every 3 months, until disease progression or initiation of other anticancer therapy for up to one year of follow-up.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| everolimus | Experimental | Drug: Everolimuseverolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Advanced RCC or a resectable renal tumor and at least one measurable inoperable metastasis (at least 1 cm), in whom anti-angiogenic therapy is indicated
- Patients without target lesions, with bone metastasis
- Histologically confirmed clear cells RCC and possibility of adequate tumor sampling prior to treatment
- No prior systemic treatment for RCC
- Male or female, at least 18 years
Key exclusion criteria (24 listed)
- Previous nephrectomy
- Histology: any histologic type different than ccRCC
- Treatment in a clinical trial in the last 30 days
- Previous treatment with everolimus or other mTOR-inhibitors and anti-angiogenic drugs
- Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack, abnormal lung function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverolimusAlso: AFINITOReverolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only) | Drug | everolimus |
Primary outcome
Objective clinical benefit
Time frame: After 6 weeks of treatment
Objective clinical benefit is defined as complete response, partial response or stable disease according to RECIST criteria version 1.1
3 secondary outcomes
Progression Free Survival
Time frame: up to 1 year
Overall survival
Time frame: up to 2 years
Safety and tolerability
Time frame: Participants will be followed all along the treatment period, an expected average of 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Oudard, MD, PhD principal investigator
Hôpital Européen Georges Pompidou, Paris (France)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus in people with Clear-cell Renal Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 10 sites 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 21 inclusion and 24 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: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective clinical benefit (time frame: After 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2016.