Completed

A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma

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What is being tested

conventional surgery

Procedure
Who is being recruted

Urogenital Diseases+13

+ Adenocarcinoma

+ Carcinoma

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 1992
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: June 12, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1992

Actual date on which the first participant was enrolled.

OBJECTIVES: Compare time to recurrence and survival of patients with single, low stage, nonmetastatic, well localized, and well delineated renal cell cancer treated with partial vs radical resection. Establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients. Study the relationship between tumor size, histologic grade, histologic type, and the extent of local control following partial resection. Determine which prognostic factors are important in selecting candidates for conservative surgery. OUTLINE: This is a randomized, multicenter study. Patients are randomized to undergo radical nephrectomy and limited lymphadenectomy (arm I) or conservative surgery (arm II). Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 1300 patients will be accrued for this study over 8 years.

NCT00002473
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: June 12, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Renal CellKidney Neoplasms

Criteria

DISEASE CHARACTERISTICS: Single renal T1-2 tumor suspicious for adenocarcinoma that meets the following requirements: Solitary tumor on CT scan Maximum diameter 5 cm Located such that negative resection margins are assured N0, M0, i.e., no nodal involvement or distant metastases No invasion of renal pelvis, calices, or perirenal fat as determined by CT scan or intravenous urography Normal contralateral kidney present No von Hippel-Lindau disease PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy except adequately treated nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Sunnybrook and Women's College Health Sciences Centre

North York, CanadaOpen Sunnybrook and Women's College Health Sciences Centre in Google Maps

McGill University

Montreal, Canada
Completed2 Study Centers