Metastasectomy Study in Renal Cell Carcinoma (RCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00918775
First received: June 10, 2009
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
Kidney Cancer
Other: Evaluation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma.

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: June 2009
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metastasectomy
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.

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:

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918775

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Eric Jonasch, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00918775     History of Changes
Other Study ID Numbers: 2009-0038
Study First Received: June 10, 2009
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Renal Cell Carcinoma
RCC
Kidney
Metastasectomy
Surgery
Tumor Removal

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

ClinicalTrials.gov processed this record on April 17, 2014