Cancer types
  • Lung
  • Urology
Title of study
Amendment to the REQUITE Study Protocol: Validating predictive models and biomarkers of radiotherapy toxicity to reduce side-effects and improve quality-of-life in cancer survivors. Extension of the follow-up to a minimum of 5 years.
Version Number
Approval Date 
7.0, 25 January 2021
Short Title
REQUITE Plus
Study site
Principle Investigator
Dr. P. Seibold; Prof. J Chang-Claude
Investigator Maastro
Prof. Dr. D. De Ruysscher
Sponsor
Trial registry
Objectives 

Grade of toxicity in the extended follow-up period, including patient-reported outcomes.

Primary Endpoint 

•Change in breast appearance at 24 months following start of radiotherapy (breast)
•Rectal bleeding at 24 months following start of radiotherapy (prostate)
•Dyspnea/ breathlessness at 12 months following start of radiotherapy (lung)

Secondary Endpoints 

•Other toxicity endpoints including but not limited to: fibrosis, induration and vascular changes (breast); rectal incontinence, urinary toxicity and erectile dysfunction (prostate); dysphagia and oesophagitis (lung)
•Quality of life
•Maximum grade of toxicity during follow-up period
•Amendment 2019: Grade of toxicity in the extended follow-up period, including patient-reported outcomes

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