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Trial registered on ANZCTR


Registration number
ACTRN12617001566325
Ethics application status
Approved
Date submitted
8/11/2017
Date registered
21/11/2017
Date last updated
18/07/2019
Date data sharing statement initially provided
18/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)
Scientific title
Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)
Secondary ID [1] 293302 0
ctDNA-08
Universal Trial Number (UTN)
U1111-1204-7664
Trial acronym
DYNAMIC-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 305386 0
Condition category
Condition code
Cancer 304672 304672 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This design incorporates two separate clinical objectives; (i) non-inferiority and (ii) benefit.
This prospective multi-centre, phase II/III randomised study aims to enrol a total of 1000 stage III colon cancer patients. Patients will be randomised 1:1 to be treated according to post-op ctDNA results (Arm B: ctDNA-informed), or per standard of care (Arm A: SOC). Enrolment will be stratified by participating centre and clinical risk groups (low risk = T1-3N1; high risk = T4 and/or N2).

Patients should be screened up to 6 weeks after surgery and tumour samples will be made available in 5 working days from consent for mutation analysis. Patients will have a blood draw during week 5-6 post-op for ctDNA analysis (ctDNA-1: post-op day 32 to day 42). Clinicians are to nominate their standard of care adjuvant chemotherapy regimen (no chemotherapy, single agent fluoropyrimidine or combination fluropyrimidine plus oxaliplatin) at the time of enrolment prior to randomisation. Randomisation will occur after the post-op ctDNA blood draw and receipt of sufficient tumour tissue. Additional blood collection time-points will depend on the schedule of adjuvant chemotherapy. Formalin-fixed paraffin embedded tumour tissue and the study bloods sample will undergo ctDNA analysis at Johns Hopkins University.

In the ctDNA-informed arm (Arm B), the post-op ctDNA result will be made available to the treating clinician approx 4-5 weeks after receipt of tumour tissue. Adjuvant chemotherapy will commence after the ctDNA result becomes available or, where the treating clinician wishes to commence adjuvant treatment before the result is available, an individual patient may commence on standard of care treatment no earlier than 6 weeks post-op, and then switch to the ctDNA informed strategy as per the protocol. Patients who are "ctDNA negative" will be managed with a de-escalation adjuvant treatment strategy and those who are "ctDNA-positive" will be managed with an escalation adjuvant treatment strategy. In the standard of care arm, patients and their clinicians will be blinded to the ctDNA results and will receive adjuvant chemotherapy as per standard of care.

Patients in Arm B receiving 3 or 6 months of adjuvant chemotherapy will have blood collection for ctDNA analysis prior to and during treatment (ctDNA-2, ctDNA-2A +/- ctDNA-2B) and at the end of treatment (ctDNA-3). These results will not be routinely made available to the patients or clinicians.

For patients where standard treatment of oxaliplatin based treatment is escalated to FOLFOXIRI, this will be given for at least 6 cycles.

TREATMENT REGIMENS:

Unless otherwise specified, duration of chemotherapy (3 or 6 months) and dose modifications on treatment are at clinician's discretion.

Recommended single agent fluoropyrimidine based chemotherapy regimens include:
1. 2 weekly De Gramont (modified)
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 400mg/m2 IV (intravenous)
c) Fluorouracil 2400mg/m2 CIV (continuous intravenous) pump over 46 hours

2. Weekly modified QUASAR
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 375-450mg/m2 IV (intravenous)(dose as per institutional standard of care)

3. Weekly modified Roswell Park (weekly for 6 weeks followed by 2 week break)
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 500mg/m2 IV (intravenous)

4. Capecitabine orally days 1 to 14, every 21 days (dose as per institutional standard of care)

Recommended combination oxaliplatin-based chemotherapy regimens include 12 or 24 weeks of:

1. 2 weekly FOLFOX6 (modified)
a) Oxaliplatin 85mg/m2 IV (intravenous)
b) Leucovorin 50mg IV (intravenous)
c) Fluorouracil 400mg/m2 IV (intravenous)
d) Fluorouracil 2400mg/m2 CIV (continuous intravenous) pump over 46 hours

2. 3 weekly CAPOX
a) Oxaliplatin 130mg/m2
b) Capecitabine 1000mg/m2 twice a day orally days 1 to 14, every 21 days

Recommended triplet chemotherapy regimen includes 12 to 24 weeks of:
1. 2 weekly FOLFOXIRI
a) Irinotecan 165mg/m2 IV (intravenous)
b) Oxaliplatin 85 mg/m2IV (intravenous)
c) Leucovorin 50mg IV (intravenous)
d) Fluorouracil 3200mg/m2 CIV (continuous intravenous) pump over 46 hours

Standard of Care Arm (Arm A)

Clinician's choice of:
- no adjuvant chemotherapy
- fluoropyrimidine chemotherapy
-combination fluoropyrimidine plus oxaliplatin chemotherapy

ctDNA-Informed Arm (Arm B)

De-escalation or escalation chemotherapy regimen will be based on clinician's chosen standard of care chemotherapy regimen prior to randomisation

Standard of care choice - no chemo
-ctDNA Negative: No adjuvant chemotherapy
-ctDNA Positive: 3 months of fluoropyrimidine alone

Standard of care choice - 6 months of fluoropyrimidine alone chemotherapy
-ctDNA Negative: No adjuvant chemotherapy or 3 months of fluoropyrimidine chemotherapy
-ctDNA Positive: 6 months of combination fluoropyrimidine plus oxaliplatin chemotherapy

Standard of care choice - 3 months of combination fluoropyrimidine plus oxaliplatin chemotherapy
-ctDNA Negative: fluoropyrimidine chemotherapy
-ctDNA Positive: 6 months of combination fluoropyrimidine plus oxaliplatin or triplet chemotherapy (FOLFOXIRI) for 6 cycles, followed by further treatment at clinician discretion.

Standard of care choice - 6 months of combination fluoropyrimidine plus oxaliplatin chemotherapy
-ctDNA Negative: fluoropyrimidine alone or 3 months of combination fluoropyrimidine plus oxaliplatin
-ctDNA Positive: triplet chemotherapy (FOLFOXIRI) for 6 cycles, followed by further treatment at clinician discretion.

Details of adjuvant chemotherapy received, including start and stop dates, dose received, dose reduction, reason for dose reduction/interruption and reason for stopping treatment will be recorded.

Interim Analysis for Futility:

Prior to completing the phase II component, futility of the observed de-escalation rate will be evaluated. After 38 patients in the ctDNA negative cohort have been enrolled and managed according to the ctDNA result, if fewer than 26 of these patients have been de-escalated then consideration will be given to either modifying the protocol or not continuing to the 100 patients in this group.
Intervention code [1] 299561 0
Early detection / Screening
Intervention code [2] 299564 0
Treatment: Drugs
Comparator / control treatment
Standard of Care Arm (Arm A)

Clinician's choice of:

1) No adjuvant chemotherapy
2) Fluoropyrimidine chemotherapy
3) Combination fluoropyrimidine plus oxaliplatin chemotherapy

Subjects and clinicians in SOC arms will be blinded to their ctDNA results and will receive adjuvant chemotherapy as per standard of care.
Control group
Active

Outcomes
Primary outcome [1] 303883 0
Primary Objective - To evaluate the impact of de-escalation/escalation treatment strategies as informed by post-op ctDNA analysis. The ctDNA positive and negative cohorts will be evaluated separately:
a. For ctDNA negative patients, the trial will evaluate that a de-escalation treatment strategy is non-inferior to standard of care treatment as measured by the rate of 3-year recurrence-free survival.
b. For the ctDNA positive patients, the trial will investigate if an escalation treatment strategy is superior to standard of care treatment as measured by the 24 month recurrence-free survival
Timepoint [1] 303883 0
Patients from all arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for recurrence. Recurrence-free survival at 3 years post randomisation is measured by the time interval between randomisation and date of first recurrence. Recurrence is defined as evidence of disease either locally or distantly. Clinical assessment, radiological work-up and histological confirmation of recurrent disease will prove the presence of recurrent disease .
Secondary outcome [1] 340352 0
To demonstrate that a ctDNA-informed adjuvant therapy approach does not compromise recurrence free survival compared to standard of care adjuvant therapy in patients with NEGATIVE post-op ctDNA.
Timepoint [1] 340352 0
Patients from all arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for survival. Overall survival is measured by the time interval between randomisation and date of death from all causes.
Secondary outcome [2] 340381 0
To correlate end of treatment ctDNA results with recurrence-free and overall survival
Timepoint [2] 340381 0
Patients who receive treatment on the ctDNA informed arm will have "on treatment" and "end of treatment" blood tests to measure their ctDNA levels at 2 to 3 defined timepoints during treatment. The timing of these tests is dependent on the treatment regimen and duration of chemotherapy. Patients will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for recurrence.

Overall survival is measured by the time interval between randomisation and date of death from all causes.
Secondary outcome [3] 372776 0
To demonstrate an acceptable rate of de-escalation in the ctDNA-informed negative cohort.
Timepoint [3] 372776 0
At interim analysis and end of study
Secondary outcome [4] 372777 0
To examine the proportion of patients in whom escalated chemotherapy has reversed the ctDNA status from positive to negative post completion of the escalated treatment regime in the ctDNA-informed positive cohort.
Timepoint [4] 372777 0
At the completion of treatment for all patients randomised to the ctDNA-informed cohort which had a positive ctDNA-1 blood result and were treated with an escalated treatment regimen. The end of treatment (ctDNA-3) sample will be analysed to determine the proportion of patients where the ctDNA status switched from positive to negative following treatment.
Secondary outcome [5] 372778 0
To compare the 3-year recurrence free survival rates between ctDNA-informed adjuvant therapy (i.e treatment escalation) and standard of care adjuvant therapy approach in patients with POSITIVE post-op ctDNA.
Timepoint [5] 372778 0
All patients who had a positive pre-treatment ctDNA blood result and have been followed up for recurrence and survival for at least 3 years.
Secondary outcome [6] 372779 0
To compare the overall survival between ctDNA-informed adjuvant therapy and standard of care adjuvant therapy approach in patients with NEGATIVE post-op ctDNA.
Timepoint [6] 372779 0
Overall survival in patients with NEGATIVE post-op ctDNA will be assessed in both cohorts of patients at study completion.
Secondary outcome [7] 372780 0
To compare the overall survival between ctDNA-informed adjuvant therapy and standard of care adjuvant therapy approach in patients with POSITIVE post -op ctDNA.
Timepoint [7] 372780 0
Overall survival will be assessed for all patients in both cohorts with a positive post-op ctDNA at end of study.

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to Arm A (Standard of Care) or Arm B (ctDNA-informed) is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods - ie. Minimisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The primary analysis will be according to the intention-to-treat (ITT) principal. A secondary analysis of the primary outcome will be performed according to per-protocol population.
Non-inferiority will be declared if the lower bound of the one-sided 97.5% CI for the difference in recurrence-free survival at 3 years post-randomisation is greater than or equal to the margin (=-?%), 7.5. The recurrence free survival proportion will be estimated from the Kaplan-Meier curve. This will be analysed using tests for differences between tow proportions.

ctDNA status at the completion of all treatment for ctDNA-1 positive patients will be summarised using N and percent. Differences between the SOC and ctDNA-informed arms in each cohort will be compared using the Chi-square test. The ctDNA results turn-around time will be summarised using descriptive statistics: the mean, standard deviation (SD), median, minimum, maximum and interquartile range (25th-75th percentiles). The proportion of patients completing planned study treatment will be compared using the chi-square test.

For continuous variables, appropriate multivariate regression (proportional hazards, logistic, linear) will be used, where appropriate. Categorical variables will be evaluated by using chi-squared tests.

Recurrence free survival, overall survival and other time to event endpoints (local control) will be analysed using the method of Kaplan-Meier and (where appropriate) competing risks. Exploratory analyses adjusting for prognostic factors will be performed using proportional hazards regression methods. Results will be expressed as the estimated hazard ratio with the corresponding 95% confidence interval.

For the ctDNA positive cohort, the 12 month recurrence-free survival rates (calculated using the method of Kaplan-Meier) will be compared using tests for the difference between two proportions. Other exploratory analyses will used similar methods as described above.

Subgroups
Analysis of benefit/non-inferiority will also be examined in the high and low clinical risk subgroups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 9362 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 9363 0
Western Private Hospital - Footscray
Recruitment hospital [3] 9364 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 9365 0
The Northern Hospital - Epping
Recruitment hospital [5] 9367 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [6] 9368 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 9370 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 9371 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [9] 9372 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [10] 9373 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [11] 9404 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [12] 14250 0
Western Hospital - Footscray - Footscray
Recruitment hospital [13] 14251 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [14] 14252 0
Melbourne Private Hospital - Parkville
Recruitment hospital [15] 14253 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [16] 14254 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [17] 14255 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment hospital [18] 14256 0
Frankston Hospital - Frankston
Recruitment hospital [19] 14257 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [20] 14258 0
Royal Hobart Hospital - Hobart
Recruitment hospital [21] 14259 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [22] 14260 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [23] 14261 0
Concord Repatriation Hospital - Concord
Recruitment hospital [24] 14262 0
Liverpool Hospital - Liverpool
Recruitment hospital [25] 14263 0
Northern Cancer Institute - St Leonards
Recruitment hospital [26] 14264 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [27] 14265 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [28] 14266 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [29] 14267 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [30] 14268 0
Gosford Hospital - Gosford
Recruitment hospital [31] 14269 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [32] 14270 0
Echuca Regional Health - Echuca
Recruitment postcode(s) [1] 18051 0
3050 - Parkville
Recruitment postcode(s) [2] 18052 0
3011 - Footscray
Recruitment postcode(s) [3] 18053 0
3128 - Box Hill
Recruitment postcode(s) [4] 18054 0
3076 - Epping
Recruitment postcode(s) [5] 18056 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 18057 0
2500 - Wollongong
Recruitment postcode(s) [7] 18059 0
5042 - Bedford Park
Recruitment postcode(s) [8] 18060 0
5011 - Woodville
Recruitment postcode(s) [9] 18061 0
4029 - Herston
Recruitment postcode(s) [10] 18062 0
6150 - Murdoch
Recruitment postcode(s) [11] 18104 0
2305 - New Lambton Heights
Recruitment postcode(s) [12] 27247 0
3000 - Melbourne
Recruitment postcode(s) [13] 27248 0
3052 - Parkville
Recruitment postcode(s) [14] 27249 0
3065 - Fitzroy
Recruitment postcode(s) [15] 27250 0
3550 - Bendigo
Recruitment postcode(s) [16] 27251 0
3280 - Warrnambool
Recruitment postcode(s) [17] 27252 0
3199 - Frankston
Recruitment postcode(s) [18] 27253 0
3350 - Ballarat Central
Recruitment postcode(s) [19] 27254 0
7000 - Hobart
Recruitment postcode(s) [20] 27255 0
2290 - Gateshead
Recruitment postcode(s) [21] 27256 0
2560 - Campbelltown
Recruitment postcode(s) [22] 27257 0
2139 - Concord
Recruitment postcode(s) [23] 27258 0
2170 - Liverpool
Recruitment postcode(s) [24] 27259 0
2065 - St Leonards
Recruitment postcode(s) [25] 27260 0
3630 - Shepparton
Recruitment postcode(s) [26] 27261 0
2485 - Tweed Heads
Recruitment postcode(s) [27] 27262 0
2340 - Tamworth
Recruitment postcode(s) [28] 27263 0
2109 - Macquarie Park
Recruitment postcode(s) [29] 27264 0
2250 - Gosford
Recruitment postcode(s) [30] 27265 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [31] 27266 0
3564 - Echuca
Recruitment outside Australia
Country [1] 9344 0
New Zealand
State/province [1] 9344 0
Christchurch

Funding & Sponsors
Funding source category [1] 297927 0
Charities/Societies/Foundations
Name [1] 297927 0
Marcus Foundation
Address [1] 297927 0
1266 W. Paces Ferry Road No. 615
Atlanta, Georgia 30327
USA
Country [1] 297927 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group
Address
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 296989 0
Other
Name [1] 296989 0
The Walter and Eliza Hall Institute of Medical Research
Address [1] 296989 0
1G Royal Parade
Parkville
VIC 3052
Country [1] 296989 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298973 0
Melbourne Health
Ethics committee address [1] 298973 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australia
Ethics committee country [1] 298973 0
Australia
Date submitted for ethics approval [1] 298973 0
30/11/2016
Approval date [1] 298973 0
22/03/2017
Ethics approval number [1] 298973 0
HREC/16/MH/388

Summary
Brief summary
The aim of this study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for stage III colon cancer.

Study details
All participants in this study will have a blood draw during week 5-6 post surgery for ctDNA analysis. They will then be randomly allocated to one of two treatment groups. One group will receive standard of care treatment as selected by their clinician: either no chemotherapy, single agent fluoropyrimidine chemotherapy or combination fluoropyrimidine plus oxaliplatin chemotherapy. Treatment selection in the other group will be informed by ctDNA blood test results.

All patients will be followed up every 3 months for 2 years, then every 6 months for 3 years in order to evaluate treatment safety and efficacy. Follow-up involves additional blood tests and radiological assessments. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision regarding adjuvant chemotherapy is not inferior to standard of care in terms of recurrence-free survival.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 78850 0
A/Prof Jeanne Tie
Address 78850 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 78850 0
Australia
Phone 78850 0
+61 3 9345 2707
Fax 78850 0
+61 3 9498 2010
Email 78850 0
jeanne.tie@petermac.org
Contact person for public queries
Name 78851 0
Dr Marlyse Debrincat
Address 78851 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 78851 0
Australia
Phone 78851 0
+61 3 9345 2895
Fax 78851 0
+61 3 9498 2010
Email 78851 0
marlyse.debrincat@mh.org.au
Contact person for scientific queries
Name 78852 0
A/Prof Jeanne Tie
Address 78852 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 78852 0
Australia
Phone 78852 0
+61 3 9 345 2707
Fax 78852 0
+61 3 9498 2010
Email 78852 0
jeanne.tie@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD may be collected at a site level. However, IPD will not be made available to the Sponsor. The data that is collected by the Sponsor will not be re-identifiable at the Sponsor level. There are safeguards in place to minimise the risk of a privacy breach. They include analysing the data on an aggregated level and access to the data in a controlled environment with only authorised study personnel. Finally, enabling the availability of IPDs will not help meet the primary and secondary objectives of the study which are dependent on the results from the study population rather than on an individual basis.
What supporting documents are/will be available?
No other documents available
Summary results
No Results