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Clinical Trials/NCT01991652
NCT01991652RecruitingNot Applicable

Collaborative Wilms Tumour Africa Project

Amsterdam UMC, location VUmc3 sites in 3 countries400 target enrollmentStarted: January 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
400
Locations
3
Primary Endpoint
Event free survival

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age < 18 years
  • Diagnosis Wilms tumour

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Event free survival

Time Frame: 2 years

Percentage of patients with no event after two years of follow up.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Amsterdam UMC, location VUmc
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Trijn Israels

Paediatric Oncologist, MD PhD

Amsterdam UMC, location VUmc

Study Sites (3)

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