Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)
- Conditions
- Colorectal CancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12617001566325
- Lead Sponsor
- Australasian Gastro-Intestinal Trials Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
1.Patients aged greater than or equal to 18 years of age
2.Subjects with curatively resected stage III (Any T, N1 or N2, M0) colon cancer
3.Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy.
4.A representative tumour sample is available for molecular testing up to 6 weeks after surgery
5.Fit for at least 3 months of fluoropyrimidine adjuvant chemotherapy
6.ECOG performance status 0-2
1.History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ
2.Patients with multiple primary colorectal cancers
3.Inadequate organ function:
a.Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation
b.Absolute neutrophil count <1.0x109/L
c.Platelet count <75x109/L
d.Haemoglobin <80 g/L
e. Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal
4.Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method