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Onderzoek naar de uitkomst van chemotherapie gevolgd door een lymfeklieroperatie en een gecombineerde behandeling van chemotherapie met uitwendige bestraling voor hoog-risico spier-ingroeiend blaaskanker (CHEMORAD-TRIAL)


- candidate number22920
- NTR NumberNTR5504
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2015
- Secondary IDsM15CRB NL51464.031.15
- Public TitleOnderzoek naar de uitkomst van chemotherapie gevolgd door een lymfeklieroperatie en een gecombineerde behandeling van chemotherapie met uitwendige bestraling voor hoog-risico spier-ingroeiend blaaskanker (CHEMORAD-TRIAL)
- Scientific TitlePROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER -CHEMORAD-TRIAL-
- ACRONYMCHEMORAD-TRIAL
- hypothesisAfter chemoradiation the bladder-preservation rate after two years followup will be around 85%
- Healt Condition(s) or Problem(s) studiedBladder carinoma
- Inclusion criteria-Signed written informed consent
-Locally advanced urothelial carcinoma of the bladder (cT3-T4) or any cT-stage with cytologically or histologically proven node positive urothelial carcinoma (or positive FDG/PET-CT-scan with suspect lymph nodes, including supraregional retroperitoneal lymph nodes below the diaphragm.
-Renal function: Creatinin clearance 50 mL/min (calculated) and serum creatinin 1.5 x UNL.
-Karnofsky performance 70
- Exclusion criteria-Distant metastases (M+)
-Severe bladder symptoms (necessitating cystectomy).
-Bilateral hydronefrosis.
-Persisting hydronephrosis after induction chemotherapy (necessitating cystectomy). A temporary nefrostomy is indicated during chemotherapy.
-Previous radiation therapy on pelvic region
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate
- Target number of participants50
- Interventions-Neoadjuvant chemotherapy
-Pelvic lymph node dissection
-Chemoradiation
- Primary outcome- Bladder-preservation rate
- No evidence of disease at 12 months followup
- Secondary outcome- Recurrence rates (local and distant)
- Toxicity rates following induction chemotherapy
- Complication rates following ePLND
- Toxicity rates following chemoradiation
- Quality of Life (EuroQol EQ-5D-3L; SF-12)
- Disease specific survival
- Recurrence free survival
- Genetic biomarkers
- TimepointsQuality of Life assessment will be performed using validated questionnaires: EuroQol EQ-5D-3L and SF-12. These questionnaires will be submitted at the following moments: T0 (entry of study); T6 (after 6 months); T12 (after 12 months); T24 (after 24 months).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD FEBU R.P. Meijer
- CONTACT for SCIENTIFIC QUERIESMD PhD FEBU R.P. Meijer
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summarySystemic treatment with cisplatin-based combination chemotherapy has been shown to improve the outcome of patients presenting with locally advanced muscle-invasive bladder cancer and patients with lymph node positive disease, albeit at best an absolute 6.5% increase in overall survival at 5-years follow-up[1-6]. Aims of the present study are: to evaluate the bladder preservation rate after chemoradiation, and furthermore assessment of the toxicity and complications of induction cisplatin-based combination chemotherapy followed by pelvic lymph node dissection (ePLND) and chemoradiation.
- Main changes (audit trail)
- RECORD30-sep-2015 - 5-jan-2016


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