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Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM)

NCT ID: NCT01230697

Last Updated: 2010-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-09-30

Brief Summary

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The study includes the recruitment of patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective observational study.

Detailed Description

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Several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown.

Sorafenib is probably the drug in which this metabolic disturbance is most frequent. The aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.

Conditions

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Kidney Cancer Liver Cancer

Keywords

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Advanced hepatocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sofanenib and Hypophosphatemia

Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib

Sorafenib

Intervention Type DRUG

Sorafenib 800mg/die oral

Interventions

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Sorafenib

Sorafenib 800mg/die oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. age over 18 years
2. Histologically documented kidney cancer or hepatocarcinoma
3. Performance status more than / equal to 2
4. Life expectancy \> 12 weeks
5. in patients with recent surgery, the wound should be completely healed before taking Sorafenib
6. required initial laboratory values: absolute neutrophil count \> 1500/ul Platelets \> 100,000/ul., Hemoglobin \> 9.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal Bilirubin less than/equal to upper limit of normal(ULN)
7. Appropriate patienty compliance

Exclusion Criteria

1. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia,
2. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
3. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent
4. Sintomatic brain metastases
5. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded
6. patients with seizures that need medical treatment
7. History of heterologous transplantation
8. Patients with previous or active bleeding
9. Dialysis patients
10. Patients with history of primary hyperparathyroidism
11. Dysphagic patients
12. Taking more than four weeks of entry into the study of other bio-chemotherapy treatments
13. Previous treatment with Sorafenib
14. Recent (\<6 months)or concomitant treatment with biphosphonate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Dipartimento di Scienze Cliniche e Biologiche - Università di Torino

Locations

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Alfredo Berruti

Orbassano (To), Turin, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Elisa Bellini, MD

Role: primary

Other Identifiers

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662010

Identifier Type: -

Identifier Source: org_study_id