N/A
Completed N=355
Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC
Source: ClinicalTrials.gov NCT04375150 ↗Enrolled (actual)
355
Serious AEs
—
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With First Line Treatment Regimen — 340; 15 Participants
Summary
The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Line Treatment Regimen |
340; 15 | — |
| PRIMARY Number of Participants With Monotherapy and Combination Therapy |
0; 0; 97; 6; 21; 1 | — |
| PRIMARY Time to First Line Therapy |
29.00; 25.00 | — |
| PRIMARY Duration of Treatment According to Each Line of Therapy |
11.97; 5.90; 5.38; 2.58; 4.03; 3.43 | — |
| PRIMARY Number of Participants With Treatment Continuation |
21; 1 | — |
| PRIMARY Number of Participants With Treatment Interruption |
171; 6 | — |
| PRIMARY Time to Treatment Interruption |
2.10; 1.05 | — |
| PRIMARY Number of Participants With Treatment Switch or Augmentation |
146; 8; 2; 0 | — |
| PRIMARY Number of Participants According to Lines of Therapy |
340; 15; 148; 8; 51; 3 | — |
| PRIMARY Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC) |
0; 7; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants According to Their Status at End of Follow-up |
161; 11; 104; 2; 75; 2 | — |
| PRIMARY Time to Treatment Failure (TTF) |
2.57; 1.83 | — |
| PRIMARY Percentage of Participants With Treatment Discontinuation |
80; 80 | — |
| PRIMARY Percentage of Participants Alive at 3 Months |
90.29; 86.67 | — |
| PRIMARY Percentage of Participants Alive at 6 Months |
82.35; 66.67 | — |
| PRIMARY Percentage of Participants Alive at 12 Months |
67.35; 40.00 | — |
| PRIMARY Overall Survival |
29.43; 11.97 | — |
Eligibility Criteria
Inclusion Criteria
- Age 20 years or older in the year of the index first line therapy prescription.
- 2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date.
- 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.)
- Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates.
- Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data
Exclusion Criteria
- Received advanced treatment prior to the study index date.
- Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed.
- Only one RCC diagnosis in the 12 months prior or one mont post index date.
- Patients with data for analysis (< 3 months post index date)
Data sourced from ClinicalTrials.gov (NCT04375150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.