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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 - Recruiting

Recruitment to the SarcoSIGHT trial was paused on 14th November 2024 and will remain paused to recruitment while certain MHRA requirements are being addressed. We are continuing to follow-up existing trial patients and to collect information from them. We will provide an update on the status of the trial as soon as it becomes available.

 

SarcoSIGHT: A Randomised-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care

  • Study stage: Recruiting
  • 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
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