Feasibility study of Neo-adjuvant (before surgery) versus Adjuvant (after surgery) chemotherapy in Upper Tract Urothelial Carcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

European Uro-Oncology Group Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-10-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

European Uro-Oncology Group (EUOG)

External identifiers

EU CT number

2024-514991-41-01

EudraCT number

2016-004017-27

ClinicalTrials.gov

NCT02969083

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based chemotherapy treatment.
To assess the proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy.
To assess the administered versus planned dose of chemotherapy in patients randomized to neo- or adjuvant chemotherapy.

Secondary objectives 1

1. To assess 1,2- and 3-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS) in patients of the three arms of the study according to intention to treat as well as per protocol analysis. • To assess safety and tolerability of three courses of neo-adjuvant compared to 3 courses of adjuvant chemotherapy. • To evaluate histopathology in each group and the histological response in the neo-adjuvant patient group.

Conditions and MedDRA coding

Upper Tract Urothelial Carcinoma. Upper urinary tract transitional cell carcinoma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. written informed consent • Age ≥ 18 years. • Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract •Patients with UTUC cT2-cT4 cN0-N1 M0 (TNM classification) •Patients must agree with Summaries of product characteristics (SmPC) contraceptive requirements •Patients without bladder cancer or with concomitant non muscle invasive bladder cancer •Adequate organ system function defined by Hematological results •CT scan of the chest, abdomen and pelvis and bone scan without evidence of distant metastasis

Exclusion criteria 1

1. •Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or predominant small cell carcinoma. •History of cardiovascular conditions within the past 6 months. •Incidentally found asymptomatic pulmonary embolism (PE) or recent deep vein thrombosis (DVT) is not an exclusion criteria but requires anticoagulation treatment. •Any major contraindication to a surgical procedure. •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. •Active infection contraindicating chemotherapy (under investigator criteria). •Other active neoplasms •Concomitant muscle invasive bladder cancer. •Patients who have received prior cisplatin based treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy

Secondary endpoints 1

1. 1- 2 and 3-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

European Uro-Oncology Group Stichting

Sponsor organisation

European Uro-Oncology Group Stichting

Address

Zernikedreef 8

City

Leiden

Postcode

2333 CL

Country

Netherlands

Scientific contact point

Organisation

European Uro-Oncology Group Stichting

Contact name

Susanne Osanto

Public contact point

Organisation

European Uro-Oncology Group Stichting

Contact name

Susanne Osanto

Locations

3 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications