REQUITE: Validating predictive models and biomarkers of radiotherapy toxicity to reduce side-effects and improve quality-of-life in cancer survivors

Completed

Conditions: malignant prostate tumour or lung tumour
prostate cancer or lung cancer
10036958
10029107

Registration Number: NL-OMON42419

Lead Sponsor: MAASTRO clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

* Confirmed diagnosis of the specified tumour types, for lung cancer confirmation either by histology or based on radiological findings
* Patients suitable for radical radiotherapy or brachytherapy for prostate cancer; including post-prostatectomy patients
* Patients suitable for radical radiotherapy, sequential or concurrent chemoradiotherapy or stereotactic body radiation therapy for lung cancer
* No other malignancy in the last 5 years prior to treatment for the specified tumour types except basal cell or squamous cell carcinoma of the skin
* No evidence of distant metastases
* Patients able to provide a venous blood sample
* Willingness and ability to comply with scheduled visits, treatment plans and available for follow up within country of origin
* Greater than 18 years of age; no upper age limit
* The capacity to understand the patient information sheet and the ability to provide written informed consent

Exclusion Criteria

* Patients with metastatic disease
* Prior irradiation at the same site
* Planned use of protons
* High Intensity Focal Ultrasound (HIFU)
* Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
* Limited life expectancy due to co-morbidity
Pregnant patients
* Patients with known HIV infection/infectious hepatitis

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Prostate: Rectal bleeding at 24 months following start of radiotherapy<br /><br>* Dyspnea/ breathlessness at 12 months following start of radiotherapy (lung)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Other toxicity endpoints including but not limited to: rectal incontinence,<br /><br>urinary toxicity and erectile dysfunction (prostate), dysphagia and<br /><br>oesophagitis (lung)<br /><br>* Quality of Life (QoL)<br /><br>* Maximum grade of toxicity during follow-up period </p><br>