NCT01547676

Brief Summary

This randomized pilot trial studies clamped or unclamped surgery in treating patients with kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

February 10, 2012

Last Update Submit

March 25, 2015

Conditions

Recurrent Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in renal function as measured by eGFR

    Measured by eGFR, MAG-3 Nuclear Renal Scan, and serum creatinine. The two arms will be compared using regression methods that will account for repeated measures and the pre-randomization stratification.

    Up to 1 year

Secondary Outcomes (7)

  • Estimated blood loss during surgery

    Up to 1 year

  • Rate of blood transfusion during and after surgery

    Up to 1 year

  • Number of patients with positive surgical margins

    Up to 1 year

  • Number of patients with complications during surgery and at 90 days post surgery

    Up to 1 year

  • Number of patients with adverse events

    Up to 1 year

  • +2 more secondary outcomes

Study Arms (2)

Arm A (unclamped partial nephrectomy)

EXPERIMENTAL

Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension.

Procedure: robot-assisted laparoscopic surgery

Arm B (clamped partial nephrectomy)

ACTIVE COMPARATOR

Patients undergo clamped partial nephrectomy.

Procedure: robot-assisted laparoscopic surgery

Interventions

robot-assisted laparoscopic surgeryPROCEDURE

Unclamped partial nephrectomy

Arm A (unclamped partial nephrectomy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solitary renal mass or solitary complex renal cyst Bosniak \>/= Grade 3
  • Clinical stage T1a, T1b
  • Body Mass Index (BMI) \< 40
  • Surgical candidate (preoperative cardiac and anesthesia clearance obtained)
  • Able to give informed consent
  • hour urine collection complete and report obtained
  • MAG-3/DTPA scan completed and report obtained

You may not qualify if:

  • Pregnancy
  • More than 1 renal mass or complex renal cyst Bosniak \>/= Grade 3 on ipsilateral kidney
  • Previous renal surgery on the ipsilateral kidney
  • Clinical Stage T2 or greater
  • BMI \> 40
  • Contraindication to systemic hypotension:
  • Left Main Coronary Arterial Disease
  • Severe cardiac decompensation (ejection fraction \[EF\] \< 40%)
  • Prior history of cerebrovascular accident
  • Unable to consent
  • Unwilling or unable to potentially receive blood transfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Mihir Desai

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

March 8, 2012

Study Start

December 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

US(1)