Collaborative Wilms Tumour Africa Project

Recruiting

• Conditions: Wilms Tumour

• Registration Number: NCT01991652
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment.

A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year.

The hypothesis is that 2 year event free survival will be 50%, with \<10% failure to complete treatment and \<10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.

Detailed Description

Patients are treated according to standard care. Data are documented on presentation at diagnosis, response of the tumor, findings at surgery and pathology, treatment given and outcome of the patients.

Study Timeline

• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-25
• Study Start: 2014-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-03
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age < 18 years
• Diagnosis Wilms tumour

Exclusion Criteria

* None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event free survival	2 years	Percentage of patients with no event after two years of follow up.

Trial Locations

Locations (3)

Mbingo Mission Hospital; 🇨🇲 Bamenda, Cameroon

Korle Bu Hospital; 🇬🇭 Accra, Ghana

College of Medicine; 🇲🇼 Blantyre, Malawi