DYNAMIC-II : Circulating tumour DNA (ctDNA) analysis informing adjuvant chemotherapy in Stage II Colon Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

UnknownPhase Unknown

18-75Age 18-75

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy | Bowel (colorectum)Colon,Rectum

Trial Overview Read MoreRead more

This study is looking at circulating DNA and how it could inform adjuvant chemotherapy for recurrence-free survival in patient with stage II colon cancer.
 

This trial is treating patients with Colon and Rectum Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Circulating tumour DNA (ctDNA) analysis informing adjuvant chemotherapy in Stage II Colon Cancer

Other Non-Commercial Sponsor

Walter and Eliza Hall Institute

Summary

This study will determine the effect of the use of circulating tumour DNA (ctDNA) to guide adjuvant chemotherapy on recurrence-free survival in stage II colon or rectal cancer patients Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with Stage II colon or rectal cancer and have had your cancer curatively resected. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have blood samples taken and analysed for circulating tumour DNA (ctDNA) and be treated according to the ctDNA results. Those with positive ctDNA results will receive standard 5FU-based adjuvant chemotherapy, while those with negative ctDNA will not receive adjuvant chemotherapy. Participants in the other group will have a blood sample taken, but the ctDNA result will not be disclosed. Patients in this group will be treated according to standard clinical criteria at the discretion of the treating physician. Participants who had positive ctDNA results and are being treated with adjuvant chemotherapy will have monthly blood samples taken during treatment to track ctDNA levels. All participants will be followed up 3 monthly for 2 years, then 6 monthly for 3 years through their hospital for a total of five years for disease recurrence and survival.

Recruiting Hospitals Read MoreRead more

Bendigo Hospital
Bendigo
Ms Amanda Rundle
arundle@bendigohealth.org.au
03 5454 8821

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9288 3167

Warrnambool Hospital
Warrnambool
Sandra Robinson
sjrobinson@swh.net.au
03 5562 9056

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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