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Identification of muscle-invasive bladder cancer patients who will not benefit from neoadjuvant chemotherapy using circulating tumor cells.


- candidate number15286
- NTR NumberNTR4120
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2013
- Secondary IDsNL44847.078.13 METC 2013-301; TRC number A301312
- Public TitleIdentification of muscle-invasive bladder cancer patients who will not benefit from neoadjuvant chemotherapy using circulating tumor cells.
- Scientific TitleIdentification of muscle-invasive bladder cancer patients who will not benefit from neoadjuvant chemotherapy using circulating tumor cells.
- ACRONYMCirguidance
- hypothesisPatients without detectable CTCs will not benefit from neoadjuvant chemotherapy.
- Healt Condition(s) or Problem(s) studiedMuscle invasive bladder cancer, Circulating tumor cells, Neoadjuvant chemotherapy
- 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 or older.
- 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 less than 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate1-nov-2017
- Target number of participants260
- InterventionsIn 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.
- Primary outcomeThe 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 outcomeSecondary 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.
- Timepoints- 2-year overall survival rate in nonmetastatic MIBC patients without detectable CTCs treated with radical local treatment without prior neoadjuvant chemotherapy.
- 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.L. Boormans
- CONTACT for SCIENTIFIC QUERIESDr. J.L. Boormans
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryBackground of the study:
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.

Objective of the study:
Primary study objective is to prospectively assess whether the presence of CTCs in the peripheral blood of nonmetastatic 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, relapsefree 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.

Study population:
Patients with stage T2-T4aN0-1M0 urothelial carcinoma of the bladder who are candidate for radical local treatment (radical cystectomy).

Primary study parameters/outcome of the study:
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.

Secundary study parameters/outcome of the study:
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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
- Main changes (audit trail)
- RECORD19-aug-2013 - 1-sep-2013


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