Metastatic Renal Cell CarcinomaRESUMENCT01827254
Sutent Rechallenge In mRCC Patients
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 18 sites in France.
Trial summary
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- sunitinib: observational study
- How many people
- 61 participants
- Where
- 18 sitesFrance
- Study dates
- Jul 2013to Apr 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line
Who may be able to join
- Histologically documented metastatic RCC containing predominantly clear cell component.
- Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
- At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
- At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
- Life expectancy of at least 3 months.
Who cannot join
- Patient who didn't receive Sunitinib in first line.
- Patient who received less than one line of treatment .
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Centre Paul Papin
Angers, 49100
Hôpital Saint-André
Bordeaux, 33075
Centre Catalan Urologie Andrologie
Cabestany, 66330
Hopital albert Michalon
Grenoble, Cedex 9, 38043
Centre Oscar Lambret - Cancérologie Urologie Digestive
Lille, 59020
clinique de la Louvière
Lille, 59042
Hopital Dupuytren - Oncologie Medicale
Limoges, 87042
Centre Leon Berard, Service d'Oncologie Medicale
Lyon, 69373
CHU de la Timone
Marseille, Cedex 5, 13335
Institut Paoli-Calmettes / Hôpital de jour
Marseille, 13273 Cedex 9
Hopital Timone Adultes
Marseille, 13385
Hopital Europeen Georges Pompidou
Paris, 75908
Centre Eugene Marquis
Rennes, 35042
CHU Charles Nicolle
Rouen, 76031
Centre Rene Gauducheau - Service Oncologie Medicale
Saint-Herblain, 44805
Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, France, 42271
Institut Claudius Regaud
Toulouse, 31000
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Etude Resume (Retraitement Sunitinib Rein Metastatique)
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Read the detailed description
A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to estimate the effect of Sutent rechallenge.
The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- sunitinib: observational study
- Keywords
- sutent rechallenge
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib: observational studyOther
Also called sunitinib 50 mg 4/2
Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line
| Study group | Role | What they receive |
|---|---|---|
| Non-Interventional Study | Not described Receives: Other: sunitinib: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival With Sunitinib as First Line of Therapy
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Measured: From start of treatment up to 66.6 months
Progression Free Survival for Re-challenge With Sunitinib
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Measured: From start of treatment up to 52.2 months
Progression Free Survival: Second Line of Treatment
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
Measured: From start of treatment up to 22.9 months
Progression Free Survival: Third Line Treatment
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
Measured: From start of treatment up to 23.7 months
Secondary outcomes (2)
Overall Survival
Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death - Start date of treatment) + 1)/365.25 x 12.
Measured: Baseline up to death or end of study (up to 98.0 months)
Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.
Measured: Baseline up to 98.0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827254
- Sponsor's protocol ID
- A6181211
- Other IDs
- ETUDE RESUME
- Acronym
- RESUME
- Status last verified
- Apr 2015
- First submitted
- 25 Mar 2013
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Resume (Retraitement Sunitinib Rein Metastatique)
- ClinicalTrials.gov ID
- NCT01827254
- Acronym / sponsor ID
- RESUME / A6181211
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- sutent rechallenge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Detailed description
A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to estimate the effect of Sutent rechallenge.
The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Interventional Study | – | Other: sunitinib: observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line
Key inclusion criteria (5 listed)
- Histologically documented metastatic RCC containing predominantly clear cell component.
- Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
- At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
- At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
- Life expectancy of at least 3 months.
Key exclusion criteria (2 listed)
- Patient who didn't receive Sunitinib in first line.
- Patient who received less than one line of treatment .
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 |
|---|---|---|
| sunitinib: observational studyAlso: sunitinib 50 mg 4/2Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line | Other | Non-Interventional Study |
Primary outcome
Progression Free Survival With Sunitinib as First Line of Therapy
Time frame: From start of treatment up to 66.6 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Progression Free Survival for Re-challenge With Sunitinib
Time frame: From start of treatment up to 52.2 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Progression Free Survival: Second Line of Treatment
Time frame: From start of treatment up to 22.9 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
Progression Free Survival: Third Line Treatment
Time frame: From start of treatment up to 23.7 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
2 secondary outcomes
Overall Survival
Time frame: Baseline up to death or end of study (up to 98.0 months)
Percentage of Participants With Objective Response
Time frame: Baseline up to 98.0 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 18 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 5 inclusion and 2 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival With Sunitinib as First Line of Therapy (time frame: From start of treatment up to 66.6 months). The study lists 4 primary outcomes in all. 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 30 Apr 2015.