Clear-cell Metastatic Renal Cell CarcinomaIMPACT-RCCNCT02228954
IMaging PAtients for Cancer Drug selecTion - Renal Cell Carcinoma (IMPACT-RCC)
An observational study of Clear-cell Metastatic Renal Cell Carcinoma and Kidney Neoplasms, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
Rationale. In part of the patients with good and intermediate risk metastatic renal cell carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is not necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear-cell Metastatic Renal Cell Carcinoma, Kidney Neoplasms
- What is being tested?
- Molecular imaging
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 3 sitesNetherlands
- Study dates
- Dec 2014to 19 Oct 2021
- Phase
- Observational
- 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
Study population: Patients with good or intermediate prognosis mccRCC according to the Heng criteria, ≥18 years, without contra-indications for a watchful waiting period, able to provide informed consent
Who may be able to join
- Histological or cytological documented mRCC with a clear cell component
- Good or intermediate prognosis, defined as none (good risk) or 1-2 intermediate risk) of the below mentioned risk factors:
- Karnofsky performance <80
- Time from diagnosis detection of metastases < 1 year
- Haemoglobin < lower limit of normal (LLN)
- Corrected calcium > upper limit of normal (ULN)
Show all 13Show fewer
- Neutrophils > ULN
- Platelets > ULN
- A watchful waiting period for 2 months is considered an option according to treating medical oncologist
- No prior systemic treatment for RCC (also non-adjuvant)
- Time from diagnosis of metastases < 3 months
- Able to provide written informed consent
- Age ≥ 18 years
Who cannot join
- Untreated central nervous system metastases, or symptomatic intracerebral metastases.
- Pregnant or breast feeding women.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that would make the subject inappropriate for study participation including any serious condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedure.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
VU University Medical Center
Amsterdam
University Medical Center Groningen
Groningen
Radboudumc
Nijmegen, 6525GA
About this study
Official title: Watchful Waiting in Patients With Good and Intermediate Risk Metastatic Renal Cell Carcinoma; an Imaging Guided Observational Approach. Part of: Towards Patient Tailored Cancer Treatment Supported by Molecular Imaging. IMPACT Study: Imaging Patients for Cancer Drug Selection
Rationale. In part of the patients with good and intermediate risk metastatic renal cell carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is not necessary. By now, the investigators are not able to identify those patients with indolent disease and the minor group of patients with rapidly progressive disease. In patients with indolent disease, a watchful waiting period is preferred, since their quality of life will not be unnecessary hampered by adverse events and therapy resistance is not induced. This study aims to identify those patients for whom a watchful waiting period is possible by molecular imaging. Furthermore several types of systemic therapy are possible once the progression is proven. These systemic treatments are comparable in terms of efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary objective, the usefulness of a decision aid guiding the choice of the patients is studied.
Objectives.
Read more
To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of:
- FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting.
- FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.
To assess the value of a therapy choice decision aid for patients with progressive disease.
Study design. This is a multicenter non-blinded prospective observational study in 80 good and intermediate prognosis mRCC patients.
Study population. Patients with good or intermediate prognosis mRCC according to the Heng criteria, ≥18 years, without contra-indications for a watchful waiting period, able to provide informed consent.
Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the watchful waiting period, disease evaluation by CT according to the RECIST criteria will be made frequently, until established progressive disease. At that moment, a second FDG-PET-CT and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second 89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a separate phase II study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness.
At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the watchful waiting period CT's will be made. During therapy, follow-up will include standard laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects of the medication and adverse events as a consequence of the tumor biopsies may occur. The radiation exposure of both PET investigations is acceptable and requires no shielding after injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or stabilization. All three treatment choices has proven clinical benefit in this patient population. The risks of participation into the RIT trial are described in the phase II trial protocol, which already has been judged by the Medical Ethics Review Committee.
- Being tested
- Molecular imaging
- Keywords
- Clear-cell metastatic renal cell carcinoma, Positron-Emission Tomography
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Renal Cell Cancer | Not described Receives: Procedure: Molecular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of:
- FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting.
- FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.
Measured: 1-5 years (End of study)
Secondary outcomes (1)
Patient and physician questionnaires on the added value of the decision aid
To assess the value of a therapy choice decision aid for patients with progressive disease
Measured: 1-5 years (End of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startDec 2014
- Primary completion5 Mar 2018
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear-cell Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228954
- Sponsor's protocol ID
- IMPACT-RCC study
- Acronym
- IMPACT-RCC
- Status last verified
- Dec 2021
- First submitted
- 26 Aug 2014
- Last updated
- 7 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watchful Waiting in Patients With Good and Intermediate Risk Metastatic Renal Cell Carcinoma; an Imaging Guided Observational Approach. Part of: Towards Patient Tailored Cancer Treatment Supported by Molecular Imaging. IMPACT Study: Imaging Patients for Cancer Drug Selection
- ClinicalTrials.gov ID
- NCT02228954
- Acronym / sponsor ID
- IMPACT-RCC / IMPACT-RCC study
- Keywords
- Clear-cell metastatic renal cell carcinoma, Positron-Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Dec 2014 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 29 Aug 2014 (estimated)
- 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.
Rationale. In part of the patients with good and intermediate risk metastatic renal cell carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is not necessary. By now, the investigators are not able to identify those patients with indolent disease and the minor group of patients with rapidly progressive disease. In patients with indolent disease, a watchful waiting period is preferred, since their quality of life will not be unnecessary hampered by adverse events and therapy resistance is not induced. This study aims to identify those patients for whom a watchful waiting period is possible by molecular imaging. Furthermore several types of systemic therapy are possible once the progression is proven. These systemic treatments are comparable in terms of efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary objective, the usefulness of a decision aid guiding the choice of the patients is studied.
Objectives.
To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of:
- FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting.
- FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.
To assess the value of a therapy choice decision aid for patients with progressive disease.
Study design. This is a multicenter non-blinded prospective observational study in 80 good and intermediate prognosis mRCC patients.
Study population. Patients with good or intermediate prognosis mRCC according to the Heng criteria, ≥18 years, without contra-indications for a watchful waiting period, able to provide informed consent.
Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the watchful waiting period, disease evaluation by CT according to the RECIST criteria will be made frequently, until established progressive disease. At that moment, a second FDG-PET-CT and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second 89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a separate phase II study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness.
At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the watchful waiting period CT's will be made. During therapy, follow-up will include standard laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects of the medication and adverse events as a consequence of the tumor biopsies may occur. The radiation exposure of both PET investigations is acceptable and requires no shielding after injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or stabilization. All three treatment choices has proven clinical benefit in this patient population. The risks of participation into the RIT trial are described in the phase II trial protocol, which already has been judged by the Medical Ethics Review Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Cell Cancer | – | Procedure: Molecular imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with good or intermediate prognosis mccRCC according to the Heng criteria, ≥18 years, without contra-indications for a watchful waiting period, able to provide informed consent
Key inclusion criteria (13 listed)
- Histological or cytological documented mRCC with a clear cell component
- Good or intermediate prognosis, defined as none (good risk) or 1-2 intermediate risk) of the below mentioned risk factors:
- A watchful waiting period for 2 months is considered an option according to treating medical oncologist
- No prior systemic treatment for RCC (also non-adjuvant)
- Time from diagnosis of metastases < 3 months
Key exclusion criteria (3 listed)
- Untreated central nervous system metastases, or symptomatic intracerebral metastases.
- Pregnant or breast feeding women.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that would make the subject inappropriate for study participation including any serious condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedure.
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 |
|---|---|---|
| Molecular imaging | Procedure or surgery | Renal Cell Cancer |
Primary outcome
Time to progression
Time frame: 1-5 years (End of study)
To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of: 1. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting. 2. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.
1 secondary outcome
Patient and physician questionnaires on the added value of the decision aid
Time frame: 1-5 years (End of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
Related trials for Clear-cell Metastatic Renal Cell Carcinoma
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1/2
A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clear-cell Metastatic Renal Cell Carcinoma and Kidney Neoplasms, run by Radboud University Medical Center at 3 sites in Netherlands.
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 13 inclusion and 3 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: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: 1-5 years (End of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2021.