Metastasectomy Study in Renal Cell Carcinoma (RCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00918775
Recruitment Status : Recruiting
First Posted : June 11, 2009
Last Update Posted : March 29, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney Cancer Other: Evaluation

Detailed Description:

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:

Every 6 months for 5 years after surgery, the following tests and procedures will be performed:

  • 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 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 have study visits 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.

Long-Term Follow-Up:

About every 6 months after your last study visit, the study staff will either review your medical records or contact you by phone or email to collect information about your health, to see how you are doing, and what anti-cancer treatments you may have received. If you are contacted by phone, the call should only last about 5 minutes each time.

This is an investigational study. Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma.
Actual Study Start Date : June 9, 2009
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Kidney cancer patients being considered for surgery
Other: Evaluation
Evaluation during and after surgery: vital signs, performance status, physical exam, chest x-ray, CT and MRI plus health questions.

Primary Outcome Measures :
  1. 24-week Progression free/relapse free survival rate [ 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. ]
    Primary outcome is binary indicator that patient is alive with no evidence of disease progression (either progression or relapse) 24 weeks post surgery (response), denoted by Y. Time of surgery considered time 0. Baseline covariates examined for their ability to predict p = Pr(Y=1) include binary variables observed at first diagnosis, at trial entry, and type of therapeutic intervention.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic renal cell carcinoma (mRCC) and will be undergoing a surgical resection of tumor.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00918775

Contact: Eric Jonasch, MD 713-792-2830

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Eric Jonasch, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00918775     History of Changes
Other Study ID Numbers: 2009-0038
1R01CA90370-01 ( Other Grant/Funding Number: NCI )
NCI-2017-00524 ( Registry Identifier: NCI-CTRP )
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Renal Cell Carcinoma
Tumor Removal

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases