Clinical trial · Observational
Sutent Rechallenge In mRCC Patients
Etude Resume (Retraitement Sunitinib Rein Metastatique)
NCT01827254CI-TRIAL-00017727RESUMEcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib: observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-Interventional Study
- interventionNames
- Other: sunitinib: observational study
Primary outcomes (4)
- measure
- Progression Free Survival With Sunitinib as First Line of Therapy
- timeFrame
- From start of treatment up to 66.6 months
- description
- 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.
- measure
- Progression Free Survival for Re-challenge With Sunitinib
- timeFrame
- From start of treatment up to 52.2 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patient who didn't receive Sunitinib in first line. * Patient who received less than one line of treatment .
References
Publications (0)
Data not yet available
No reference posted for this study.