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Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma

NCT01342627 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2015-10-06

No results posted yet for this study

Summary

Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65 years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib.

Each patient treated with sorafenib enrolled in the study will be trained to observe the management tool for skin care. A study period of 3 years was estimated as follows: an enrollment period of 24 months and a further follow-up period of 12 months.

Objectives of the trial Primary objective The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of Hand-Foot Skin Reaction (HFSR).

Secondary Objectives

TO assess:

* The frequency of dose discontinuation, interruption and reduction
* The incidence of any grade diarrhoea, and other adverse events
* The overall Response Rate according to the RECIST criteria.
* Progression free survival (PFR) in study population and comparison of PFS between age sub groups in the current study population

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

DRUG

Sorafenib

Sorafenib will be orally administered at a daily dose of 400 mg taken twice daily without food, at least one hour before or two hours after eating. Four weeks of treatments will be considered as a cycle. Each patient enrolled in the study will received medications for topical therapy. Dermatological medications will be provided free. In case of toxicities, dose reduction/interruption is permitted according to the protocol. In case of disease progression Sorafenib administration will be discontinued.

Sponsors & Collaborators

  • Centro di Riferimento Oncologico - Aviano

    lead OTHER

Principal Investigators

  • Lucia Fratino, oncologist · Centro di Riferimento Oncologico - IRCCS - Aviano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01342627 on ClinicalTrials.gov