Trial · NCT04033991
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. |
| Primary | Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | PFS: first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<lower limit of normal (LLN); lactate dehydrogenase 1.5\*upper limit of normal (ULN); corrected serum calcium \>10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was considered PD. |
| Primary | Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | PFS: duration measured from first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. IMDC criteria had 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10 mg/dL; neutrophils and platelets \>LLN; hemoglobin \<LLN. Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered PD. |
| Secondary | Overall Survival (OS) | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. |
| Secondary | Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. MSKCC criteria had 5 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<LLN; lactate dehydrogenase 1.5\* ULN; corrected serum calcium \>10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing = no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. |
| Secondary | Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. IMDC criteria had 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10.0 mg/dL; neutrophils and platelets \>LLN and hemoglobin \<LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing =no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. |
| Secondary | Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1 | Start of treatment till BOR of CR, PR, PD, SD, Surgical CR, or death/initiation of new therapy, whichever occurred first; from 2002 to 30 June 2018, anytime in these 16 years (data retrieved and observed retrospectively for approximately 1.2 years) | BOR was recorded for CR, PR, SD, PD and surgical CR. RECIST v1.1, a) CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \<10mm; b) PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; c) PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5mm. Appearance of 1 or more new lesions; d) SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start; e) Surgical CR: disappearance of target, non-target lesions, normalization of tumor markers, pathological lymph nodes had short axis measuring \<10mm as result of surgery. Alive participants with no events were censored at final study cutoff date. |
| Secondary | Objective Response Rate (ORR) | From start of treatment until CR,PR,PD,death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16 years (from data retrieved and observed retrospectively for approximately 1.2 years) | ORR was defined as the percentage of participants who achieved a BOR of CR or PR as per RECIST v1.1. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was considered progression. Alive participants who did not have event were censored at final study cutoff date. |
| Secondary | Duration of Response (DOR) | From date of first documented CR/PR until PD/death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16years (data retrieved and observed retrospectively for approximately 1.2 years) | DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. Alive participants who did not have event were censored at final study cutoff date. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. |
| Secondary | Time to Treatment Discontinuation (TTD) | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. |
| Secondary | Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. MSKCC criteria had following 5 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<LLN; lactate dehydrogenase 1.5\*ULN; corrected serum calcium \>10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing = no information available. |
| Secondary | Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. IMDC criteria had following 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10.0 mg/dL; neutrophils and platelets \>LLN and hemoglobin \<LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing =no information available. |
| Secondary | Durable Response Rate (DRR) | 6 months from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | DRR was determined as the percentage of participants with objective response (CR or PR) with a duration of at least 6 months. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. |
| Other | Number of Participants Who Started Systemic Therapy Within 1 Year of Diagnosis | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) | |
| Other | Number of Participants With Karnofsky Performance Status (KPS) Less Than 80 Percent (%) | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) | KPS: used for rating participant activities of daily living on scale from 0-100, higher score = participant is better able to carry out daily activities. Score range: 100 = normal no complaints; no disease evidence, 90 = able to carry normal activity; minor signs/symptoms of disease, 80 = normal activity with effort; some signs/symptoms, 70 = cares for self; unable to carry on normal activity, 60 = requires occasional assistance, but able to care for most personal needs, 50 = requires considerable assistance and frequent medical care, 40 = disabled; requires special care, assistance, 30 = severely disabled; hospital admission is indicated although death not imminent, 20 = very sick; hospital admission necessary, 10 = moribund; fatal processes progressing rapidly and 0 = dead. The lower the score the worse is survival for most serious illnesses. Here, number of participants with KPS \<80% were reported. |
| Other | Number of Participants With Hemoglobin Less Than Lower Limit of Normal (LLN) | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) | In this outcome measure number of participants with hemoglobin less than LLN were reported. For male participants LLN was 130 grams per liter and for female participants LLN was 115 grams per liter. |
| Other | Number of Participants With Serum Calcium >Upper Limit of Normal (ULN), Neutrophil >ULN, Platelets >ULN and Lactate Dehydrogenase >1.5*ULN | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) | Number of participants with serum calcium \>ULN (3.00 millimole per liter \[mmol/L\]), neutrophils \>ULN (7.5 \*10\^9/L), platelets \>ULN (400 \*10\^9/L), lactate dehydrogenase \>1.5\*ULN were reported in this outcome measure. |
| Other | Number of Participants Per Tumor Fuhrman Grades | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) | The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer \[mcm\]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at \*400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at \*100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. |
| Other | Number of Participants With Tumor Subtype | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) | In this outcome measure, number of participants were classified according to tumor subtype as clear cell, non-clear cell and unknown/missing. |
| Other | Number of Participants With Adverse Events | From start of treatment until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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