Collaborative Wilms Tumour Africa Project
|ClinicalTrials.gov Identifier: NCT01991652|
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : November 15, 2016
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 or disease||Phase|
|Wilms Tumour||Phase 4|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Collaborative Wilms Tumour Africa Project|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
Children diagnosed with a Wilms tumour receive SIOP PODC Wilms tumour treatment; preoperative chemotherapy, surgery and postoperative chemotherapy (= standard care).
One group of patients.
- Event free survival [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991652
|Contact: Trijn Israels, MD PhDfirstname.lastname@example.org|
|Contact: Elizabeth Molyneux, Profemail@example.com|
|Mbingo Mission Hospital||Recruiting|
|North West Cameroon, Cameroon|
|Contact: Peter Hesseling firstname.lastname@example.org|
|Principal Investigator: Francine Kouya, MD|
|Tikur Anbessa Specialized Hospital||Recruiting|
|Addis Abeba, Ethiopia|
|Contact: Haileyesus David, MD email@example.com|
|Principal Investigator: Yasar Celiker, MD|
|Korle Bu Hospital||Recruiting|
|Contact: Lorna Renner, MD firstname.lastname@example.org|
|Principal Investigator: Lorna Renner, MD|
|College of Medicine||Recruiting|
|Contact: Elizabeth Molyneux, Prof email@example.com|
|Contact: Neil Kennedy, Prof firstname.lastname@example.org|
|Principal Investigator: Elizabeth Molyneux, Prof|
|Study Chair:||Trijn Israels, MD PhD||VU University Medical Center|