Primary study objective is to prospectively assess whether the presence of CTCs in the peripheral blood of non-metastatic MIBC patients can identify patients with such a good prognosis not justifying neoadjuvant chemotherapy. Secondary study…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for this study will be the 2-year overall survival rate in
nonmetastatic MIBC patients without detectable CTCs treated with radical local
treatment without prior neoadjuvant chemotherapy.
Secondary outcome
Secondary endpoints include 2-year overall survival in the remaining patients
and cancer-specific survival, relapse-free survival, local relapse-free
survival and metastasis-free survival for all the patients. In addition, the
expression pattern of the 20-gene panel is also a secondary endpoint.
Background summary
Non-metastatic muscle-invasive bladder cancer (MIBC) is a potential lethal
disease as half of the patients develop metastases after curative treatment.
Neoadjuvant chemotherapy followed by radical treatment gives a statistically
significant, though limited survival benefit (hazard ratio 0.84 (95% CI,
0.72-0.99) at 10 years). However, as neoadjuvant chemotherapy can be
accompanied by severe toxicity, physicians are reluctant to embed neoadjuvant
chemotherapy leading to different treatment approaches across centers.
Identification of patients who will and who will not benefit from neoadjuvant
chemotherapy is therefore of great clinical relevance.
Study objective
Primary study objective is to prospectively assess whether the presence of CTCs
in the peripheral blood of non-metastatic MIBC patients can identify patients
with such a good prognosis not justifying neoadjuvant chemotherapy. Secondary
study objectives include the association of CTC-positivity or negativity with
cancer-specific survival, relapse-free survival, local relapse-free survival
and metastasis-free survival, as well as assessing the prognostic value of a
20-gene expression profile in non-metastatic MIBC patients and its added value
to a CTC count.
Study design
Prospective, open study.
Intervention
In all patients, CTCs will be enumerated. If no CTCs are detected, the patient
will proceed to undergo local radical treatment (radical cystectomy) and will
not receive neoadjuvant chemotherapy. In the case CTCs are detected, patients
may undergo neoadjuvant chemotherapy followed by radical local treatment,
dependent on the local guidelines.
Study burden and risks
In all patients, 10 mL blood for CTC enumeration will be drawn at baseline
during another blood draw that is already required for standard care. It is
hypothesized that patients without detectable CTCs will not benefit from
neoadjuvant chemotherapy, sparing this particular group of patients from a
toxic and expensive treatment.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Histopathologically confirmed muscle-invasive urothelial carcinoma of the bladder.
- Clinical stage T2-T4a N0-N1 bladder cancer.
- Candidate for radical local treatment consisting of radical cystectomy.
- Age * 18 years.
- Signed informed consent
Exclusion criteria
- Muscle-invasive bladder cancer other than urothelial carcinoma (adenocarcinoma, squamous cell carcinoma, small cell carcinoma, neuro-endocrine tumor).
- History of other malignant disease with a tumor-free interval of * 5 years.
- Known or suspected coincidental prostate cancer.
- Metastatic disease at staging, as assessed by a CT-scan of thorax and abdomen
- Local or systemic adjuvant treatment after radical cystectomy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44847.078.13 |
| Other | NTR TC4120 |