Clinical trial NCT01991652: Collaborative Wilms Tumour Africa Project
Official title: Collaborative Wilms Tumour Africa Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wilms Tumour
Keywords: Wilms tumour
Childhood cancer
Africa
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children (\< 18 years) diagnosed with a Willms tumour

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.

Eligibility criteria: Inclusion Criteria:

* Age \< 18 years
* Diagnosis Wilms tumour

Exclusion Criteria:

\* None

Primary outcomes:
measure: Event free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bamenda
country: Cameroon
facility: Mbingo Mission Hospital
city: Accra
country: Ghana
facility: Korle Bu Hospital
city: Blantyre
country: Malawi
facility: College of Medicine
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Trijn Israels, MD PhD
role: STUDY_CHAIR
References:
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 Cancer. 2013 Jan;60(1):5-11. doi: 10.1002/pbc.24321. Epub 2012 Sep 26.
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. doi: 10.1002/pbc.24501. Epub 2013 Feb 25.
citation: Israels 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/nrclinonc.2013.137. Epub 2013 Jul 30.