Clinical trial NCT00918775: Follow-up After Metastasectomy in Patients With Kidney Cancer
Official title: A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Cell Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-06-11
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with renal cell carcinoma that have been deemed resectable

Brief summary: This phase II trial studies the follow-up after metastasectomy in patients with kidney cancer. Following up patients' health condition after metastasectomy may help doctors to learn if the surgical removal of the 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.

Detailed description: PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

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

OUTLINE:

After metastasectomy, patients are followed up every 6 months for up to 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed renal cell carcinoma (RCC)
* Patients have clinical reasons for undergoing a surgical resection of tumor; there are two main categories of patients:

  * 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)
  * Patients undergoing a noncurative procedure for relief of symptoms or for management of threatening lesions
* Patients have been deemed resectable by the subspecialty surgeon involved in the patient's care
* 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
* Patients must have ability to comply with study and/or follow-up procedures
* Members of all races and ethnic groups are eligible for this trial

Exclusion Criteria:

* Patients must not have active acute infections that could be worsened by surgery or interfere with this study
* Patients must not have clinically significant cardiovascular disease, or peripheral vascular disease that creates an unacceptably high operative risk
* 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
* Patients must not have a history of uncontrolled severe depression

Primary outcomes:
measure: Binary indicator that the patient is alive with no evidence of disease progression (either progression or relapse) post surgery
timeFrame: 24 weeks
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: Disease free survival (DFS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eric Jonasch
role: PRINCIPAL_INVESTIGATOR
References: