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Trial registered on ANZCTR


Registration number
ACTRN12612000327886
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
21/03/2012
Date last updated
21/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Circulating Tumour DNA as a Marker of Complete Pathological Response and Long Term Outcome for Locally Advanced Rectal Cancer Treated with Pre-operative Chemoradiotherapy
Scientific title
Circulating Tumour DNA as a marker of complete pathological response and long term outcome for locally advanced rectal cancer treated with pre-operative chemoradiotherapy.
Secondary ID [1] 280186 0
Nil
Secondary ID [2] 280189 0
Nil
Universal Trial Number (UTN)
U1111-1129-1350
Trial acronym
ctDNA Rectal cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with locally advanced rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy. 286069 0
Nil 286124 0
Condition category
Condition code
Cancer 286264 286264 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an exploratory prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from patients with locally advanced
rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy. Patients will be treated and followed according to standard
practice.The collection of serial blood samples at specifed timepoints. The timepoints are as follows Timepoint 1 baseline (prior to chemo radiation), timepoint 2 4 – 6 weeks post chemo-radiation and the final timepoint (timepoint 3)being 4 – 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected. Each patient’s treating surgeon will assess and document the clinical response to CRT prior to surgery. Resected tumour samples will be made available after surgery for mutation analysis. If there is no or minimal residual disease in the resected specimen, then the preoperative diagnostic biopsy will be used. Histology slides will be made available for central assessment of pathological response to chemoradiation. Follow-up will be as per standard practice, including 3-monthly CEA and annual CT chest/abdomen/pelvis for at least 2 years.
Intervention code [1] 284510 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286727 0
To demonstrate that the eradication of circulating tumour DNA (ctDNA) in peripheral blood following completion of pre-operative chemoradiotherapy (CRT) is a sensitive and specific predictor of complete pathological response (pCR) in locally advanced rectal cancer.
Timepoint [1] 286727 0
Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.
Secondary outcome [1] 296544 0
To demonstrate that a reduction in ctDNA following CRT is a sensitive and specific marker of pathological response in locally advanced rectal cancer.
Timepoint [1] 296544 0
Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.
Secondary outcome [2] 296642 0
To demonstrate that the persistence of ctDNA in peripheral blood, either following CRT or surgery, is a sensitive and specific predictor of subsequent local or distant disease recurrence.
Timepoint [2] 296642 0
Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.
Secondary outcome [3] 296643 0
To demonstrate that mutations detected in ctDNA reliably predict the mutation profile of the primary tumours of these patients.
Timepoint [3] 296643 0
Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.

Eligibility
Key inclusion criteria
1. Patients with histologically confirmed adenocarcinoma of the rectum
2. Patients with radiologically defined locally advanced disease on pelvic MRI (mT3, mT4 or mN+) or endorectal ultrasound (uT3, uT4 or uN1) where MRI is contraindicated)
3. No evidence of metastatic disease on CT chest/abdomen/pelvis
4. Patients planned to receive long-course chemoradiation followed by curative surgery and adjuvant 5-fluorouracil or capecitabine chemotherapy
5. Patients willing to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of another primary cancer within the last 5 years, with the exception of nonmelanomatous skin cancer and carcinoma in situ of the cervix.
2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
3. Patients with major organ impairment
4. Patients that are not accessible for follow-up

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284897 0
Government body
Name [1] 284897 0
National Health and medical Coucil
Country [1] 284897 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Ludwig Institute for Cancer Research
Address
PO Box 2008
RMH Post Office
Parkville VIC 3050 Australia
Country
Australia
Secondary sponsor category [1] 283776 0
None
Name [1] 283776 0
Address [1] 283776 0
Country [1] 283776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286892 0
Melbourne Health HREC
Ethics committee address [1] 286892 0
Ethics committee country [1] 286892 0
Australia
Date submitted for ethics approval [1] 286892 0
Approval date [1] 286892 0
08/03/2012
Ethics approval number [1] 286892 0
HREC/11/MH/397

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33924 0
Address 33924 0
Country 33924 0
Phone 33924 0
Fax 33924 0
Email 33924 0
Contact person for public queries
Name 17171 0
Philippa Robertson
Address 17171 0
PO Box 2008, RMH Post Office Parkville VIC 3050 Australia
Country 17171 0
Australia
Phone 17171 0
+61(3)9342 4584
Fax 17171 0
Email 17171 0
philippa.robertson@ludwig.edu.au
Contact person for scientific queries
Name 8099 0
Dr Jeanne Tie
Address 8099 0
PO Box 2008, RMH Post Office Parkville VIC 3050 Australia
Country 8099 0
Australia
Phone 8099 0
+61(3) 9342 3037
Fax 8099 0
Email 8099 0
jeanne.tie@ludwig,edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSerial circulating tumour DNA analysis during multimodality treatment of locally advanced rectal cancer: A prospective biomarker study.2019https://dx.doi.org/10.1136/gutjnl-2017-315852
N.B. These documents automatically identified may not have been verified by the study sponsor.