Colorectal CancercmPATNCT06167967
Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer
A study testing ctDNA methylation and standard treatment in people with Colorectal Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ctDNA methylation and standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age < 75 years old.
- Stage III (T1-4, N1-2, M0) colorectal cancer patients.
- Patients who can undergo R0 resection.
- ECOG score 0 ~ 2.
- Expected survival ≥ 6 months.
- No history of other malignant tumors.
- Voluntarily participate in this study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.
Who cannot join
- Patients who have received neoadjuvant chemotherapy.
- Known high clinical risk of adjuvant chemotherapy.
- Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age).
- Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance).
- Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.
- There are any other circumstances that the researcher deems unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shao hospital
Hanzhou, Zhejiang, 310016
Zhangfa Song, Dr, +86 13867421652, songzhangfa@zju.edu.cn
Zhangfa Song, doctor
About this study
Official title: Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer: a Multicenter, Randomized Controlled Trial
The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are:
- Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients.
- Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients.
325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.
- Conditions
- Colorectal Cancer
- Being tested
- ctDNA methylation, standard treatment
- Keywords
- colorectal cancer, ctDNA methylation, adjuvant chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA methylationDiagnostic test
A blood-based circulating tumor DNA methylation assay that uses 6 different methylation markers, SEPT9 region1, SEPT9 region2, BCAT1, IKZF1, BCAN and VAV3.
standard treatmentDiagnostic test
This group was treated according to standard procedure
| Study group | Role | What they receive |
|---|---|---|
| ctDNA-guided group | Experimental | ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months; ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months; ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months; ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy. Receives: Diagnostic Test: ctDNA methylation |
| standard treatment group | Active comparator | The standard treatment group in the high-risk cohort were treated with XELOX regimen for 6 months, and in the low-risk cohort were treated with XELOX regimen for 3 months. Receives: Diagnostic Test: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival at 3 years
Measured: 3 years
Secondary outcomes (3)
Overall survival at 5 years
Measured: 5 years
ctDNA clearance rate in ctDNA-positive patients treated with adjuvant chemotherapy
Measured: 6 months
The proportion of patients in the low-risk cohort who did not receive adjuvant chemotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start8 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangfa Song, Sir Run Run Shaw Hospital
- Investigators
- Zhangfa Song, Dr, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167967
- Sponsor's protocol ID
- SRRS-cmPAT
- Other IDs
- SRRS2023-0704
- Acronym
- cmPAT
- Status last verified
- May 2024
- First submitted
- 4 Dec 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06167967
- Acronym / sponsor ID
- cmPAT / SRRS-cmPAT
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, ctDNA methylation, adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are:
- Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients.
- Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients.
325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA-guided group | Experimental | Diagnostic Test: ctDNA methylationctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months; ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months; ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months; ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy. |
| standard treatment group | Active comparator | Diagnostic Test: standard treatmentThe standard treatment group in the high-risk cohort were treated with XELOX regimen for 6 months, and in the low-risk cohort were treated with XELOX regimen for 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old ≤ age < 75 years old.
- Stage III (T1-4, N1-2, M0) colorectal cancer patients.
- Patients who can undergo R0 resection.
- ECOG score 0 ~ 2.
- Expected survival ≥ 6 months.
Key exclusion criteria (6 listed)
- Patients who have received neoadjuvant chemotherapy.
- Known high clinical risk of adjuvant chemotherapy.
- Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age).
- Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance).
- Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNA methylationA blood-based circulating tumor DNA methylation assay that uses 6 different methylation markers, SEPT9 region1, SEPT9 region2, BCAT1, IKZF1, BCAN and VAV3. | Diagnostic test | ctDNA-guided group |
| standard treatmentThis group was treated according to standard procedure | Diagnostic test | standard treatment group |
Primary outcome
Recurrence-free survival at 3 years
Time frame: 3 years
3 secondary outcomes
Overall survival at 5 years
Time frame: 5 years
ctDNA clearance rate in ctDNA-positive patients treated with adjuvant chemotherapy
Time frame: 6 months
The proportion of patients in the low-risk cohort who did not receive adjuvant chemotherapy
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhangfa Song, Dr principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ctDNA methylation and standard treatment in people with Colorectal Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingjun Bai, Dr (+8613858816897, echobai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival at 3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.