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A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma.


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Open (Enrolling)
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Kidney Cancer

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Trial Information

A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma.


This research study is designed to follow your progress after the surgery is complete. You
will not receive any drugs or treatment as part of this research study. You may however
receive non-study treatment after your surgery.

Study Visits:

Right before you have surgery, the following tests and procedures will be performed:

- Your vital signs will be measured.

- Your performance status will be recorded.

- Blood (about 2-3 teaspoons) and urine will be collected for routine tests.

- You will be asked about any side effects you may have experienced since your last
visit.

About 1 month after the surgery, the following tests and procedures will be performed:

- You will be asked about any drugs and/or treatments you may be receiving.

- You will be asked about any side effects you may have experienced since your last
visit.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 2-3 teaspoons) and urine will be collected for routine tests.

Every 3 months for the 1st year after surgery (Year 1), every 4 months for the 2nd year
after surgery (Year 2), and again every 6 months for the 3rd through 5th years after surgery
(Years 3-5), the following tests and procedures will be performed:

- You will be asked about any drugs and/or treatments you may be receiving.

- You will be asked about any side effects you may have experienced since your last
visit.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 2-3 teaspoons) and urine will be collected for routine tests.

- You will have a chest x-ray and CT scans or MRI scans of your chest, stomach area, and
brain to check the status of the disease.

- If the study doctor thinks it is necessary, you will have a bone scan to check the
status of the disease.

Length of Study:

You will remain on study for up to 5 years after the surgery is complete. You will be taken
off study early if the disease gets worse, or if the study doctor thinks that it is no
longer in your best interest to continue.

This is an investigational study. Up to 56 patients will take part in this study. All will
be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patients with histologically or cytologically confirmed renal cell carcinoma (RCC).

2. 2. Patients have clinical reasons for undergoing a surgical resection of tumor. There
are two main categories of patients: a)Patients with fully resectable disease as
defined by lesions accessible by a surgeon during no more than two separate surgical
sessions, and are expected to be rendered surgically no evidence of disease (NED). b)
Patients undergoing a noncurative procedure for relief of symptoms or for management
of threatening lesions.

3. Patients have been deemed resectable by the subspecialty surgeon involved in the
patient's care

4. Patients must give written informed consent prior to initiation of therapy, in
keeping with the policies of the institution. Patients with a history of major
psychiatric illness must be judged able to fully understand the investigational
nature of the study and the risks associated with the therapy. The only approved
consent is attached to this protocol

5. Patients must have ability to comply with study and/or follow-up procedures.

6. Both men and women and members of all races and ethnic groups are eligible for this
trial.

Exclusion Criteria:

1. Patients must not have active acute infections that could be worsened by surgery or
interfere with this study.

2. Patients must not have clinically significant cardiovascular disease, or peripheral
vascular disease that creates an unacceptably high operative risk.

3. Patients must not have history of other diseases, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates surgical resection, or render the subject
at high risk from treatment complications.

4. Patients must not have a history of uncontrolled severe depression.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

24-week Progression free/relapse free survival rate

Outcome Time Frame:

Every 3 months for the first year, every 4 months during the second year, every 6 months in the third through fifth year.

Safety Issue:

No

Principal Investigator

Eric Jonasch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0038

NCT ID:

NCT00918775

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Renal Cell Carcinoma
  • RCC
  • Kidney
  • Metastasectomy
  • Surgery
  • Tumor Removal
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030