Collaborative Wilms Tumour Africa Project

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by VU University Medical Center
Sponsor:
Collaborator:
International Society of Pediatric Oncology (SIOP)
Information provided by (Responsible Party):
Trijn Israels, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01991652
First received: November 12, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01991652

Contacts
Contact: Trijn Israels, MD PhD +31.6.42717920 t.israels@vumc.nl
Contact: Elizabeth Molyneux, Prof emmolyneux@gmail.com

Locations
Cameroon
Mbingo Mission Hospital Not yet recruiting
North West Cameroon, Cameroon
Contact: Peter Hesseling       pbh@sun.ac.za   
Principal Investigator: Francine Kouya, MD         
Ethiopia
Tikur Anbessa Specialized Hospital Not yet recruiting
Addis Abeba, Ethiopia
Contact: Yasar Celiker, MD       myceliker@gmail.com   
Principal Investigator: Yasar Celiker, MD         
Ghana
Korle Bu Hospital Not yet recruiting
Accra, Ghana
Contact: Lorna Renner, MD       lornarenner@gmail.com   
Principal Investigator: Lorna Renner, MD         
Malawi
College of Medicine Not yet recruiting
Blantyre, Malawi
Contact: Elizabeth Molyneux, Prof       emmolyneux@gmail.com   
Contact: Neil Kennedy, Prof       n.kennedy@medcol.mw   
Principal Investigator: Elizabeth Molyneux, Prof         
Tanzania
Muhimbili Hospital Not yet recruiting
Dar es Salaam, Tanzania
Contact: Trish Scanlan, MD       trishascan@hotmail.com   
Principal Investigator: Lulu Chirande, MD         
Uganda
National Cancer Institute Not yet recruiting
Kampala, Uganda
Contact: Jackson Orem, Prof       jacksonorem@yahoo.co.uk   
Principal Investigator: Joyce Balagadde, MD         
Sponsors and Collaborators
VU University Medical Center
International Society of Pediatric Oncology (SIOP)
Investigators
Study Chair: Trijn Israels, MD PhD VU University Medical Center
  More Information

Publications:
Responsible Party: Trijn Israels, Paediatric Oncologist, MD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01991652     History of Changes
Other Study ID Numbers: CollabWilmsAfrica
Study First Received: November 12, 2013
Last Updated: November 21, 2013
Health Authority: Malawi: College of Medicine Research and Ethics Committee

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

Additional relevant MeSH terms:
Wilms Tumor
Neoplasms
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

ClinicalTrials.gov processed this record on October 23, 2014