Actively Recruiting
Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
Led by University of Southampton · Updated on 2024-11-12
25
Participants Needed
14
Research Sites
211 weeks
Total Duration
On this page
Sponsors
U
University of Southampton
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multicentre, single arm, open label UK phase II trial to assess the efficacy of trastuzumab deruxtecan in reducing micrometastatic disease burden in HER2 positive GOA patients who are ctDNA positive after chemotherapy and surgery. 25 patients will be recruited from approximately 15 NHS secondary care sites.
CONDITIONS
Official Title
Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed adenocarcinoma of the stomach, gastroesophageal junction, or lower oesophagus with HER2 overexpression
- Positive circulating tumor DNA (ctDNA) after surgery
- Completed at least six weeks of neoadjuvant chemotherapy before surgery
- Surgical removal of tumor with clear margins (R0)
- Recovered from surgery as assessed by the investigator
- No prior treatment with trastuzumab or other HER2 therapies
- No metastatic disease on post-surgical CT scan
- ECOG performance status of 0 to 1
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before treatment
- Adequate organ and bone marrow function as specified
- For women of childbearing potential, negative pregnancy test and use of effective contraception
- Male participants sexually active with female partners must use condoms with spermicide and follow contraception guidelines
- Ability to provide informed consent
You will not qualify if you...
- Uncontrolled illnesses or infections that could interfere with study participation
- Recent heart problems within 6 months, including heart attack or unstable angina
- Prolonged QT interval on ECG
- History or suspicion of interstitial lung disease or pneumonitis
- Severe lung diseases or autoimmune conditions affecting the lungs
- Complete removal of a lung (pneumonectomy)
- Uncontrolled infections requiring intravenous treatment
- Multiple recent primary cancers except certain treated skin or in situ cancers
- Presence of fluid buildup requiring drainage in chest, abdomen, or heart sac
- Unresolved toxicities from previous cancer treatments above specified grade
- Allergies or hypersensitivity to trastuzumab deruxtecan or similar drugs
- Pregnancy or breastfeeding
- Current involvement in planning or conducting this study
- Substance abuse or medical conditions interfering with study participation
- Receipt of live vaccine within 30 days before first dose
- Active immunodeficiency, HIV, or active hepatitis B or C infection
- Investigator judgement that participation is not suitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Royal Surrey NHS Foundation Trust, Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Not Yet Recruiting
2
University Hospitals Coventry and Warwickshire, University Hospital Coventry
Coventry, Warwickshire, United Kingdom, CV2 2DX
Actively Recruiting
3
Belfast Health and Social Care Trust, Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
4
Cambridge University Hospital NHS Foundation Trust, Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
5
University Hospitals of Derby and Burton NHS Foundation Trust, Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
Actively Recruiting
6
NHS Tayside, Ninewells Hospital
Dundee, United Kingdom, DD2 1UB
Actively Recruiting
7
Hull University Teaching Hospitals NHS Trust, Castel Hill Hospital
Hull, United Kingdom, HU16 5JQ
Actively Recruiting
8
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
9
University College London Hospitals NHS Foundation Trust, University College Hospital London
London, United Kingdom, NW1 2BU
Actively Recruiting
10
Guys & St Thomas NHS Foundation Trust, Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
11
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
12
Oxford University Hospitals NHS Trust, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
13
Lancashire Teaching Hospitals NHS Foundation Trust, Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Actively Recruiting
14
Velindre University NHS Trust, Velindre Cancer Centre
Whitchurch, United Kingdom, CF14 2TL
Not Yet Recruiting
Research Team
E
Elizabeth Smyth
CONTACT
D
Daniel Griffiths
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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