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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00524 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2009-0038 | Other Identifier | M D Anderson Cancer Center | |
| R01CA90370 | Other Identifier | National Cancer Institute |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (follow-up) | Other | After metastasectomy, patients are followed up every 6 months for up to 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-Up Care | Other | Undergo follow-up |
| |
| Laboratory Biomarker Analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Binary indicator that the patient is alive with no evidence of disease progression (either progression or relapse) post surgery | Assessed using a logistic regression model. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Up to 5 years | |
| Overall survival (OS) | Will be analyzed by Kaplan Meier plots and appropriate regression analyses using the vector of intervention indicators (ZD, ZE, ZI) as covariates, with the model determined by preliminary goodness-of-fit analyses. |
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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 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:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Jonasch | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000359 | Aftercare |
| ID | Term |
|---|---|
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
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| Other |
Correlative studies |
|
| Up to 5 years |
| Disease free survival (DFS) | Will be analyzed by Kaplan Meier plots and appropriate regression analyses using the vector of intervention indicators (ZD, ZE, ZI) as covariates, with the model determined by preliminary goodness-of-fit analyses. | Up to 5 years |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |