Cancer, Neoplasm
CaPP3 - Follow-up
CaPP3- A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme
- Study stage: Follow-up
- Sponsor: Newcastle upon Tyne Hospitals NHS Foundation Trust
- Funder: Cancer Research UK, Bayer Pharma AG
- Therapeutic area: Cancer and Neoplasm
- Type of study: CTIMP
Aim: To find the best dose of aspirin that people with Lynch syndrome should take to prevent cancer. The CAPP2 trial showed that 600mg aspirin per day for 2 years reduced the incidence of colorectal cancer by over 50%.
Primary outcome:
The number of new primary mismatch repair deficient cancers (“Lynch syndrome cancers”) at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
- Population: Adult
- Phase: III
- Design: RCT
- Setting: Secondary care
- Planned Sample Size: 1567
Website: http://www.capp3.org/
Liteform - Closed
A Randomised Controlled Trial of the Clinical and Cost Effectiveness of Low Level Laser in the Management of Oral Mucositis in Head and Neck Cancer Irradiation
- Study stage: Closed
- Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Funder: NIHR – HTA
- Therapeutic area: Cancer and Neoplasm
- Type of study: CE Marked Device
Aim: To establish the benefit of Low Level Laser Therapy (LLLT) delivered 3 times weekly delivered by trained staff in the management of oral mucositis in head and neck cancer irradiation.
Primary outcome:
OMWQ-HN score at week 6 following start of LLLT treatment.
- Population: Adult
- Design: RCT
- Setting: Secondary Care
- Planned Sample Size: 380
Variant - Closed
The Prostate Cancer Androgen Receptor Splice Variant 7 Biomarker Study- A multicentre randomised feasibility trial of biomarker-guided personalised treatment in patients with advanced prostate cancer
- Study stage: Closed
- Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Funder: NIHR – Research for Patient Benefit
- Therapeutic area: Cancer and Neoplasm
- Type of study: Non clinical intervention
Aim: To determine the feasibility of a definitive randomised control trial to evaluate the clinical utility of an AR-V7 blood biomarker assay in personalising treatment for men with mCRPC in UK NHS clinical practice.
Primary Outcome:
To establish if it is feasible to conduct a definitive large-scale pragmatic trial comparing AR-V7 biomarker-driven management with the current standard of care in patients with metastatic Castration-Resistant Prostate Cancer.
- Population: Adult
- Design: RCT
- Setting: Secondary Care
- Planned Sample Size: 70
Spirit 2 - Closed
STI571 Prospective International RandomIsed Trial 2 – A phase III, prospective randomised comparison of imatinib 400mg daily versus dasatinib 100mg in patients with newly-diagnosed chronic phase chronic myeloid leukaemia.
- Study stage: Closed
- Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Funder: IIT (Bristol Myer Sqibb)
- Therapeutic area: Cancer and Neoplasm
- Type of study: CTIMP
Aim: To compare 5 year event free survival between the treatment arms.
- Clinical Phase: III
- Population: Adult
- Design: RCT
- Setting: Secondary Care
- Planned Sample Size: 810
SarcoSIGHT - Set-up
SarcoSIGHT: A Randomised-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care
- Study stage: Set-up
- Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Funder: National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme
- Therapeutic area: Cancer and Neoplasm
- Type of study: Surgical
Aim: To determine whether FGS using ICG reduces the UPM rate compared to the current standard of care (SoC).
Primary Outcome: The UPM rate, defined as the percentage of patients with an unexpected positive margin, will be compared between the two treatment arms.
- Population: Adult
- Design: RCT (open label)
- Setting: Secondary Care
- Planned Sample Size: 500