PROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER

PROSPECTIVE 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43780

Enrollment

Registered

2016-03-31

Start date

2015-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'bladder cancer' and 'high-risk muscle invasive bladder cancer'

Interventions

After initial staging and informed consent, patients will receive induction chemotherapy followed by ePLND and chemoradiation. Induction chemotherapy consists primarily of a cisplatin-based regimen,

Bladder Cancer

Bladderpreservation

Chemoradiation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All patients with locally advanced (T3-4) and/or node positive bladder cancer (>=N1), who are fit to receive cisplatin-based combination chemotherapy and who are eligible for surgery, may be included in this study. ;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 =70

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
-To evaluate the bladder-preservation rate after chemoradiation -To evaluate the recurrence of disease after 12 months followup, following chemoradiation	—

Secondary

Measure	Time frame
- 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	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)