Collaborative Wilms Tumour Africa Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by VU University Medical Center
Information provided by (Responsible Party):
Trijn Israels, VU University Medical Center Identifier:
First received: November 12, 2013
Last updated: December 9, 2014
Last verified: December 2014

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.

Condition Intervention Phase
Wilms Tumour
Drug: SIOP PODC Wilms tumour treatment: Preoperative chemotherapy
Procedure: SIOP PODC Wilms tumour treatment: surgery
Drug: SIOP PODC Wilms tumour treatment: post operative chemotherapy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Collaborative Wilms Tumour Africa Project

Resource links provided by NLM:

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wilms tumour
Children diagnosed with a Wilms tumour receive SIOP PODC Wilms tumour treatment; preoperative chemotherapy, surgery and postoperative chemotherapy.
Drug: SIOP PODC Wilms tumour treatment: Preoperative chemotherapy Procedure: SIOP PODC Wilms tumour treatment: surgery Drug: SIOP PODC Wilms tumour treatment: post operative chemotherapy


Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age < 18 years
  • Diagnosis Wilms tumour

Exclusion Criteria:

* None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01991652

Contact: Trijn Israels, MD PhD +31.6.42717920
Contact: Elizabeth Molyneux, Prof

Mbingo Mission Hospital Recruiting
North West Cameroon, Cameroon
Contact: Peter Hesseling   
Principal Investigator: Francine Kouya, MD         
Tikur Anbessa Specialized Hospital Not yet recruiting
Addis Abeba, Ethiopia
Contact: Yasar Celiker, MD   
Principal Investigator: Yasar Celiker, MD         
Korle Bu Hospital Recruiting
Accra, Ghana
Contact: Lorna Renner, MD   
Principal Investigator: Lorna Renner, MD         
College of Medicine Recruiting
Blantyre, Malawi
Contact: Elizabeth Molyneux, Prof   
Contact: Neil Kennedy, Prof   
Principal Investigator: Elizabeth Molyneux, Prof         
Muhimbili Hospital Not yet recruiting
Dar es Salaam, Tanzania
Contact: Trish Scanlan, MD   
Principal Investigator: Lulu Chirande, MD         
National Cancer Institute Recruiting
Kampala, Uganda
Contact: Jackson Orem, Prof   
Principal Investigator: Joyce Balagadde, MD         
Sponsors and Collaborators
VU University Medical Center
Study Chair: Trijn Israels, MD PhD VU University Medical Center
  More Information

Responsible Party: Trijn Israels, Paediatric Oncologist, MD PhD, VU University Medical Center Identifier: NCT01991652     History of Changes
Other Study ID Numbers: CollabWilmsAfrica
Study First Received: November 12, 2013
Last Updated: December 9, 2014
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by VU University Medical Center:
Wilms tumour
Childhood cancer

Additional relevant MeSH terms:
Wilms Tumor
Genetic Diseases, Inborn
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on October 07, 2015