Spots Global Cancer Trial Database for Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

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Trial Identification

Brief Title: Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

Official Title: A Phase II Study of an Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

Study ID: NCT04644432

Conditions

Metastatic Renal Cell Carcinoma

Kidney Neoplasm

Urologic Neoplasms

Urogenital Neoplasms

Interventions

Medication (A specification is listed under each arm)

Patient reported outcomes measurement

Study Description

Brief Summary: The purpose of the open-label INDIGO-study is to examine whether a first line individualized treatment strategy based on DNA and RNA analyses from the patient's tumor is feasible. Moreover, to involve the patient further in their treatment via patient-reported outcomes (PRO) measurements in a value-based healthcare setup with simultaneous analyses of the financial costs of this strategy. The patients are assigned into 4 treatment arms according to the results of their DNA and RNA analyses. All patients receive electronic questionnaires regarding symptoms and side effects weekly and questionnaires regarding quality of life monthly. Based on each patient's answers of the questionnaires the patient receives advices in the app to reduce the symptoms and side effects or the patient is instructed to contact the hospital. The hypothesis: Basing the choice of first-line treatment for DNA mutations and RNA profiles in a heterogeneous patient population increases the overall response rate for the total population to 30% compared to 10% for historical cohorts.

Detailed Description: