Renal Cell CarcinomaPhase 2ROBOCOPNCT04534998
Robotic-assisted vs. Open Partial Nephrectomy
A Phase 2 study testing Partial nephrectomy in people with Renal Cell Carcinoma, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2020to 15 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for elective partial nephrectomy for renal neoplasms
- Patient must be at least 18 years old and capable to consent
- abdominal MRI or CT scan
- curative-intent surgery
- robotic-assisted and open approach for surgery are both feasible
- ability of patient to understand the goal, consequences and alternatives of participation in the trial
- written informed consent
Who cannot join
- patients with solitary kidney
- multiple kidney tumors
- emergency intervention, for example because of bleeding or perforation
- 2nd malignancy that will make PN needless, this does not include secondary malignancies which are under curative treatment or cases in which death from RCC is more likely
- patient belongs to a vulnerable patient group
- simultaneous 2nd surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Urology, University Medical Center Mannheim, University of Heidelberg
Mannheim, Baden-Wurttemberg, 68167
Maximilian C. Kriegmair, M.D., maximilian.kriegmair@umm.de
Karl-Friedrich Kowalewski, M.D., karl-friedrich-kowalewski@umm.de
About this study
Official title: ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial
ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial.
Read the detailed description
Surgical excision is the gold standard for the treatment for localized kidney cancer. An organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. Partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. Although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. The ROBOCOP-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase III study. 50 patients are to be included in the trial within a period of 15 months. The primary endpoint is feasibility of patient recruitment. In addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Partial nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial nephrectomyProcedure or surgery
Also called nephron-sparing surgery
Partial nephrectomy for localized kidney cancer as curative treatment.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted partial nephrectomy | Experimental | Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach. Receives: Procedure: Partial nephrectomy |
| Open partial nephrectomy | Active comparator | Partial nephrectomy will be performed using an open retroperitoneal approach. Receives: Procedure: Partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of randomized patients in relation to the eligible ones.
Measured: 15 months
Secondary outcomes (25)
Perioperative complications
Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death
Measured: throughout patient´s hospital stay, on average 6 days
Postoperative complications
Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death
Measured: 90 days
Self-reported generic health status
Patient-reported generic health status using EQ-5D-5L(EuroQol-5D-5L) questionnaire (the scale ranges from 0 to 100, with 100 representing the highest health status)
Measured: 90 days
Self-reported quality of life assessment of cancer patients
Cancer patients will be reporting their quality of life making use of the questionnaire QLQ-C30 (Quality of Life Questionnaire C30) (range 0-100, high scores represent a better quality of life)
Measured: 90 days
Self-reported quality of life in patients with kidney disease
Patients will assess the influence of their kidney disease on everyday activities, work status, social interactions, mental and physical health making use of KDQOL-SF (Kidney Disease Quality of Life Short Form), ranging from 0 ("worst possible health") to 10 ("best possible health")
Measured: 90 days
Self-assessment of depression in patients ≥ 65 years old
Elderly patients (≥ 65 years old) will report their depression symptoms filling GDS (Geriatric Depression Scale) questionnaire, ranging from 0 to 30, with 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Measured: 90 days
Self-evaluation of cancer disease´s influence on elderly patients´ life
Elderly patients (≥ 65 years old) will evaluate the influence of their cancer disease on their life (activities of daily living, cognition, mood, nutritional status, mobility, polypharmacy and social support), on a scale ranging from 0 to 17, 17 indicating the best outcome possible on quality of life.
Measured: 90 days
Self-assessment of comorbidity in elderly patients
Elderly patients (≥ 65 years old) will make use of SCQ (Self-Administered Comorbidity Questionnaire) to assess common comorbidities; a higher score indicates higher comorbidities (range 0-39)
Measured: 90 days
Postoperative self-reported quality of life
Participants will evaluate their postoperative quality of life on a 0-100 scale, higher scores indicating a better quality of life and return to daily life activities.
Measured: 90 days
Kidney function - creatinine
postoperative change in kidney function - creatinine (measured in mg/dL)
Measured: 90 days
Kidney function - GFR
postoperative change in kidney function - glomerular filtration rate (measured in mL/min)
Measured: 90 days
Length of hospital stay
Total time of hospital stay
Measured: throughout patient´s hospital stay, on average 6 days
Operative time
Surgery duration
Measured: Immediately after surgery
Inflammatory response - leucocytes
postoperative course of inflammatory parameters (leucocytes, unit of measure: white cells x10^9/L)
Measured: throughout patient´s hospital stay, on average 6 days
Inflammatory response - C-reactive protein
postoperative course of inflammatory parameters (c-reactive protein, measured in mg/L)
Measured: throughout patient´s hospital stay, on average 6 days
Inflammatory response
postoperative course of inflammatory parameters (IL-6, TNF-α, IL-1β, VEGF, measured in ng/L)
Measured: throughout patient´s hospital stay, on average 6 days
Surgical ergonomics
Surgeons will be asked to evaluate localized muscle pain on a scale from 0 to 10, 10 indicating extreme discomfort
Measured: Immediately after surgery
Surgical ergonomics
Surgeons will be asked to fill NASA TLX questionnaire (NASA Task Load Index). Range: 0-100, high scores indicate a high task load
Measured: During surgery
Resection status
Rate of R0/R1 status in each arm
Measured: up to 5 days
Use of analgesia
Need for pain medications
Measured: throughout patient´s hospital stay, on average 6 days
Trifecta outcomes of partial nephrectomy
Trifecta is defined as no major complication, R0-resection status and ischemia time of less than 25 minutes
Measured: 90 days
Blood loss
Blood loss during surgery
Measured: Immediately after surgery
Conversion to open surgery
Rate of conversion to open surgery
Measured: Immediately after surgery
Conversion to radical nephrectomy
Rate of conversion to radical nephrectomy
Measured: Immediately after surgery
Case cost
DRG-related case costs per arm
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start15 Jun 2020
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Dietmar Hopp Stiftung
- Responsible party
- Principal investigator, Karl-Friedrich Kowalewski, Universitätsmedizin Mannheim
- Investigators
- Maximilian C. Kriegmair, M.D., Study director, Department of Urology, University Medical Center Mannheim, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534998
- Sponsor's protocol ID
- 2020-542N
- Acronym
- ROBOCOP
- Status last verified
- Sep 2021
- First submitted
- 16 Aug 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient information might be shared after signing a data sharing agreement and IRB approval
Publications
Kowalewski KF, Neuberger M, Sidoti Abate MA, Kirchner M, Haney CM, Siegel F, Westhoff N, Michel MS, Honeck P, Nuhn P, Kriegmair MC. Randomized Controlled Feasibility Trial of Robot-assisted Versus Conventional Open Partial Nephrectomy: The ROBOCOP II Study. Eur Urol Oncol. 2024 Feb;7(1):91-97. doi: 10.1016/j.euo.2023.05.011. Epub 2023 Jun 12.
PubMed 37316398Kowalewski KF, Sidoti Abate MA, Neuberger M, Kirchner M, Krisam R, Egen L, Haney CM, Siegel F, Michel MS, Honeck P, Nuhn P, Westhoff N, Kriegmair MC. ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol. BMJ Open. 2021 Nov 3;11(11):e052087. doi: 10.1136/bmjopen-2021-052087.
PubMed 34732486
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT04534998
- Acronym / sponsor ID
- ROBOCOP / 2020-542N
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- Heidelberg University, Dietmar Hopp Stiftung
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial.
Detailed description
Surgical excision is the gold standard for the treatment for localized kidney cancer. An organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. Partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. Although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. The ROBOCOP-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase III study. 50 patients are to be included in the trial within a period of 15 months. The primary endpoint is feasibility of patient recruitment. In addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted partial nephrectomy | Experimental | Procedure: Partial nephrectomyPartial nephrectomy will be performed using a robotic-assisted laparoscopic approach. |
| Open partial nephrectomy | Active comparator | Procedure: Partial nephrectomyPartial nephrectomy will be performed using an open retroperitoneal approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- scheduled for elective partial nephrectomy for renal neoplasms
- Patient must be at least 18 years old and capable to consent
- abdominal MRI or CT scan
- curative-intent surgery
- robotic-assisted and open approach for surgery are both feasible
Key exclusion criteria (6 listed)
- patients with solitary kidney
- multiple kidney tumors
- emergency intervention, for example because of bleeding or perforation
- 2nd malignancy that will make PN needless, this does not include secondary malignancies which are under curative treatment or cases in which death from RCC is more likely
- patient belongs to a vulnerable patient group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial nephrectomyAlso: nephron-sparing surgeryPartial nephrectomy for localized kidney cancer as curative treatment. | Procedure or surgery | Open partial nephrectomy, Robotic-assisted partial nephrectomy |
Primary outcome
Recruitment rate
Time frame: 15 months
Proportion of randomized patients in relation to the eligible ones.
25 secondary outcomes
Perioperative complications
Time frame: throughout patient´s hospital stay, on average 6 days
Postoperative complications
Time frame: 90 days
Self-reported generic health status
Time frame: 90 days
Self-reported quality of life assessment of cancer patients
Time frame: 90 days
Self-reported quality of life in patients with kidney disease
Time frame: 90 days
Self-assessment of depression in patients ≥ 65 years old
Time frame: 90 days
Self-evaluation of cancer disease´s influence on elderly patients´ life
Time frame: 90 days
Self-assessment of comorbidity in elderly patients
Time frame: 90 days
Postoperative self-reported quality of life
Time frame: 90 days
Kidney function - creatinine
Time frame: 90 days
Kidney function - GFR
Time frame: 90 days
Length of hospital stay
Time frame: throughout patient´s hospital stay, on average 6 days
Operative time
Time frame: Immediately after surgery
Inflammatory response - leucocytes
Time frame: throughout patient´s hospital stay, on average 6 days
Inflammatory response - C-reactive protein
Time frame: throughout patient´s hospital stay, on average 6 days
Inflammatory response
Time frame: throughout patient´s hospital stay, on average 6 days
Surgical ergonomics
Time frame: Immediately after surgery
Surgical ergonomics
Time frame: During surgery
Resection status
Time frame: up to 5 days
Use of analgesia
Time frame: throughout patient´s hospital stay, on average 6 days
Trifecta outcomes of partial nephrectomy
Time frame: 90 days
Blood loss
Time frame: Immediately after surgery
Conversion to open surgery
Time frame: Immediately after surgery
Conversion to radical nephrectomy
Time frame: Immediately after surgery
Case cost
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Derived from this study: PubMed 37316398Kowalewski KF, Neuberger M, Sidoti Abate MA, Kirchner M, Haney CM, Siegel F, Westhoff N, Michel MS, Honeck P, Nuhn P, Kriegmair MC. Randomized Controlled Feasibility Trial of Robot-assisted Versus Conventional Open Partial Nephrectomy: The ROBOCOP II Study. Eur Urol Oncol. 2024 Feb;7(1):91-97. doi: 10.1016/j.euo.2023.05.011. Epub 2023 Jun 12.
- Derived from this study: PubMed 34732486Kowalewski KF, Sidoti Abate MA, Neuberger M, Kirchner M, Krisam R, Egen L, Haney CM, Siegel F, Michel MS, Honeck P, Nuhn P, Westhoff N, Kriegmair MC. ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol. BMJ Open. 2021 Nov 3;11(11):e052087. doi: 10.1136/bmjopen-2021-052087.
- Individual participant dataSharing planned: Yes. Patient information might be shared after signing a data sharing agreement and IRB approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian C. Kriegmair, M.D. study director
Department of Urology, University Medical Center Mannheim, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Partial nephrectomy in people with Renal Cell Carcinoma, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl-Friedrich Kowalewski, M.D. (00496213832201, karl-friedrich.kowalewski@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534998, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.