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Completed

NCT Number: NCT01728948

Sorafenib in Elderly mRCC

This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
  • >=65 years of age
  • Patients who have signed the informed consent
  • Patients with a life expectancy of ≥12 weeks
  • No prior systemic treatment

Exclusion criteria

  • The approved local product label must be followed for the exclusion criteria

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

treatment (including dose, duration, modification) decided by the investigator

Primary outcomes

  1. Overall survival

    Time frame: up to 2.5 years

Secondary outcomes

  1. Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria

    Time frame: up to 2.5 years

  2. Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria

    Time frame: up to 2.5 years

  3. Survival rate by one year

    Time frame: up to 1 year

  4. Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability

    Time frame: up to 3.5 years

  5. Patient characteristics (birthdate (at least year), sex, weight, height, etc)

    Time frame: up to 2.5 years

  6. Response rate (RR)

    Time frame: up to 3.5 years

  7. Time to first relief of clinical symptoms and physical signs

    Time frame: up to 3.5 years

  8. Treatment pattern

    Time frame: up to 3.5 years

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Nov 20, 2012
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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