Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence o… (NCT01575548) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
United States129 participantsStarted 2012-08-08
Plain-language summary
This randomized phase III trial studies how well pazopanib hydrochloride works compared to placebo in treating patients with kidney cancer that has spread to other parts of the body and have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient must be at least 18 years of age at the time of randomization
* Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen
* Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)
* Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization. Any number of prior metastasectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration. The most recent procedure may be nephrectomy for a renal primary tumor
* Patients with synchronous disease at initial diagnosis must have metastatic (M1) disease (American Joint Committee on Cancer \[AJCC\] 7th edition T1-4N0-1M1)
* Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative
* Patients presenting with metachronous disease may have distant metastases, regional lymph node or renal bed recurrence. Recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease
* Patient must have no evidence of disease on post-operative imaging:
* A computed t…
What they're measuring
1
Disease-free Survival (DFS)
Timeframe: Assessed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually up to 6 years