MDACC Study Summary 2009-0038

Study Summary
No. 2009-0038:.......Kidney......Eric Jonasch......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2009-0038

Study Title:	A Phase II Metastasectomy Study for Patients with Renal Cell Carcinoma.

Physician

New Patient Referral



Name:	Eric Jonasch	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Kidney	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients are required to return for follow-up visits 1 month post-surgery, every 3 months for the first year, every 4 months for year 2, and every 6 months for years 3-5.

Treatment Agents:	None	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn if the surgical removal of your primary tumor or the parts of the cancer that has spread to other parts of the body is a good method for treating patients who have kidney cancer. Only the parts of the cancer that has spread will be removed during the surgery.

Study Objectives / Outcomes

Primary:

To assess the 24-week progression free/relapse free survival rate in patients undergoing metastasectomy for metastatic renal cell carcinoma (mRCC)

Secondary:

To evaluate progression free survival (PFS), relapse free survival (RFS) and overall survival (OS) in patients undergoing metastasectomy.

2. To evaluate tissue determinants predictive for resectability, PFS and OS in patients undergoing metastasectomy.

Study Status Information



Study Activation / Registration Date:	06/09/2009

IRB Review and Approval Date:	04/14/2009

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00918775
Study Information on Clinical Trials Registry (clinicaltrials.gov)