Collaborative Wilms Tumour Africa Project

Wilms Tumour Clinical Trial

Official title:

Collaborative Wilms Tumour Africa Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991652
• Other study ID #: CollabWilmsAfrica
• Status: Recruiting
• Start date: January 2014
• Est. completion date: December 2024

Study information

• Verified date: December 2019
• Source: VU University Medical Center
• Contact: Trijn Israels, MD PhD
• Phone: +31.6.42717920
• Email: t.israels[@]vumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age < 18 years

• Diagnosis Wilms tumour

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Wilms Tumor
• Wilms Tumour

Locations

Country	Name	City	State
Cameroon	Mbingo Mission Hospital	Bamenda
Ghana	Korle Bu Hospital	Accra
Malawi	College of Medicine	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Countries where clinical trial is conducted

Cameroon,  Ghana,  Malawi, 

References & Publications (3)

Israëls T, Kambugu J, Kouya F, El-Mallawany NK, Hesseling PB, Kaspers GJ, Eden T, Renner L, Molyneux EM. Clinical trials to improve childhood cancer care and survival in sub-Saharan Africa. Nat Rev Clin Oncol. 2013 Oct;10(10):599-604. doi: 10.1038/nrclino — View Citation

Israels T, Moreira C, Scanlan T, Molyneux L, Kampondeni S, Hesseling P, Heij H, Borgstein E, Vujanic G, Pritchard-Jones K, Hadley L. SIOP PODC: clinical guidelines for the management of children with Wilms tumour in a low income setting. Pediatr Blood Can — View Citation

Israels T, Renner L, Hendricks M, Hesseling P, Howard S, Molyneux E; Paediatric Oncology in Developing Countries. SIOP PODC: recommendations for supportive care of children with cancer in a low-income setting. Pediatr Blood Cancer. 2013 Jun;60(6):899-904. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival	Percentage of patients with no event after two years of follow up.	2 years