Stage III Colorectal CancerNCT05161585
Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study
A study testing ctDNA dynamic monitoring in people with Stage III Colorectal Cancer and Circulating Tumor DNA, run by Fudan University at 1 site in China.
Trial summary
For patients with stage III colon cancers, radical resection of primary tumor followed by adjuvant chemotherapy is currently the standard treatment. Adjuvant chemotherapy with 5-fluorouracil and oxaliplatin based regimen has been proved effective to improve recurrence-free survival and overall survival. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stage III Colorectal Cancer, Circulating Tumor DNA
- What is being tested?
- ctDNA dynamic monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤80 years old, regardless of gender;
- Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2;
- Pathologically confirmed as stage III colorectal cancer;
- Radical operation performed ;
- With expected survival of more than 12 months;
- The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.
Who cannot join
- Neoadjuvant therapy performed before operation;
- Blood transfusion performed during operation or within 2 weeks before operation;
- Incomplete baseline samples, including preoperative plasma samples, surgical tumor tissue samples and plasma samples 3-7 days after operation;
- Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point
- Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
- Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer;
Show all 10Show fewer
- Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms;
- Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency;
- Significant impairment of important organ function;
- Other conditions in which the investigator believes that the patient should not participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Junjie Peng, MD, PhD, 86-18017317122, pengjj67@hotmail.com
Yaqi Li, MD, PhD, 86-15902194450, yaqili702@hotmail.com
About this study
For patients with stage III colon cancers, radical resection of primary tumor followed by adjuvant chemotherapy is currently the standard treatment. Adjuvant chemotherapy with 5-fluorouracil and oxaliplatin based regimen has been proved effective to improve recurrence-free survival and overall survival. Approximately half of patients with stage III colon cancers can be cured by surgery alone, while a substantial number of patients still experience recurrence, even with standard adjuvant chemotherapy. In recent years, circulating tumor DNA (ctDNA) has been detected in the cell-free component of peripheral blood samples in advanced colorectal cancers and many other solid tumors. Several previous studies have suggested that in patients with stage I-III colorectal cancer, postoperative ctDNA was an valuable biomarker to predict minimal residual disease (MRD) after radical resection, thus redefining patients risk outcome groups and guiding postoperative treatment. In addition, recent studies based on serial postoperative ctDNA detection showed that serial ctDNA analyses revealed disease recurrence up to 5-16.5 months ahead of radiological imaging. Here, based on the role of ctDNA in predicting MRD, we conducted an open, prospective, randomized controlled phase II cohort study to explore if ctDNA can as a biomarker to guide personalized surveillance strategy after surgery.
- Conditions
- Stage III Colorectal Cancer, Circulating Tumor DNA
- Being tested
- ctDNA dynamic monitoring
- Keywords
- Surveillance strategy, Stage III colorectal cancer, Circulating tumor DNA
- 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 dynamic monitoringDiagnostic test
ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA dynamic monitoring + routine postoperative follow-up | Experimental | ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total. At the same time, routine postoperative follow-up is given.
To be pointed out, after the completion of the adjuvant chemotherapy, if the ctDNA test indicates positive, patients will immediately perform chest, abdominal and pelvic CT and other imaging tests to determine whether there is recurrence /metastasis. If it is not confirmed, repeat the imaging review every two months, and continue to perform ctDNA test every three months. If the following ctDNA test is negative for two consecutive times, the above imaging reexamination will return to the routine follow-up frequency. In addition, during the follow-up, the following situations may occur: the imaging examination has found recurrence/metastasis, but the ctDNA test is still negative. At this time, the patient will be informed and treated in time of the recurrence/metastasis. Receives: Diagnostic Test: ctDNA dynamic monitoring |
| routine postoperative follow-up | No intervention | Only routine postoperative follow-up is given as follows: Physical examination and CEA were performed every 3-6 months for the first 2 years, every 6 months within the third to fifth year, and then annually. Chest/abdominal/pelvis computed tomography was performed annually for up to 5 years, and colonoscopy was performed for proper patients the first year after treatment and repeated in the third year if no advanced adenoma was found and then every 5 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis
Measured: Up to 60 months.
Specificity of postoperative ctDNA in monitoring recurrence and metastasis
Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
Measured: Up to 60 months.
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
True positive+True negative/sample size
Measured: Up to 60 months.
Secondary resection rate
The rate of R0 resection for recurrence or metastasis after surgery of the primary
Measured: Up to 60 months.
Secondary outcomes (5)
ctDNA-disease free survival (DFS)
Disease free survival time under ctDNA monitoring
Measured: Under ctDNA monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
CT-DFS
Disease free survival time under imaging monitoring
Measured: Under imaging monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
△DFS
The difference between ctDNA-DFS and CT-DFS
Measured: Up to 60 months.
overall survival (OS)
Overall survival of included patients
Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.
ctDNA clearance rate
The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy
Measured: Up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Nov 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161585
- Sponsor's protocol ID
- ctDNA- phaseIIICRC
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT05161585
- Acronym / sponsor ID
- ctDNA- phaseIIICRC
- Conditions
- Stage III Colorectal Cancer, Circulating Tumor DNA
- Keywords
- Surveillance strategy, Stage III colorectal cancer, Circulating tumor DNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 17 Dec 2021 (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.
For patients with stage III colon cancers, radical resection of primary tumor followed by adjuvant chemotherapy is currently the standard treatment. Adjuvant chemotherapy with 5-fluorouracil and oxaliplatin based regimen has been proved effective to improve recurrence-free survival and overall survival. Approximately half of patients with stage III colon cancers can be cured by surgery alone, while a substantial number of patients still experience recurrence, even with standard adjuvant chemotherapy. In recent years, circulating tumor DNA (ctDNA) has been detected in the cell-free component of peripheral blood samples in advanced colorectal cancers and many other solid tumors. Several previous studies have suggested that in patients with stage I-III colorectal cancer, postoperative ctDNA was an valuable biomarker to predict minimal residual disease (MRD) after radical resection, thus redefining patients risk outcome groups and guiding postoperative treatment. In addition, recent studies based on serial postoperative ctDNA detection showed that serial ctDNA analyses revealed disease recurrence up to 5-16.5 months ahead of radiological imaging. Here, based on the role of ctDNA in predicting MRD, we conducted an open, prospective, randomized controlled phase II cohort study to explore if ctDNA can as a biomarker to guide personalized surveillance strategy after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA dynamic monitoring + routine postoperative follow-up | Experimental | Diagnostic Test: ctDNA dynamic monitoringctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total. At the same time, routine postoperative follow-up is given. To be pointed out, after the completion of the adjuvant chemotherapy, if the ctDNA test indicates positive, patients will immediately perform chest, abdominal and pelvic CT and other imaging tests to determine whether there is recurrence /metastasis. If it is not confirmed, repeat the imaging review every two months, and continue to perform ctDNA test every three months. If the following ctDNA test is negative for two consecutive times, the above imaging reexamination will return to the routine follow-up frequency. In addition, during the follow-up, the following situations may occur: the imaging examination has found recurrence/metastasis, but the ctDNA test is still negative. At this time, the patient will be informed and treated in time of the recurrence/metastasis. |
| routine postoperative follow-up | No intervention | –Only routine postoperative follow-up is given as follows: Physical examination and CEA were performed every 3-6 months for the first 2 years, every 6 months within the third to fifth year, and then annually. Chest/abdominal/pelvis computed tomography was performed annually for up to 5 years, and colonoscopy was performed for proper patients the first year after treatment and repeated in the third year if no advanced adenoma was found and then every 5 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤80 years old, regardless of gender;
- Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2;
- Pathologically confirmed as stage III colorectal cancer;
- Radical operation performed ;
- With expected survival of more than 12 months;
Key exclusion criteria (10 listed)
- Neoadjuvant therapy performed before operation;
- Blood transfusion performed during operation or within 2 weeks before operation;
- Incomplete baseline samples, including preoperative plasma samples, surgical tumor tissue samples and plasma samples 3-7 days after operation;
- Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point
- Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
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 dynamic monitoringctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total. | Diagnostic test | ctDNA dynamic monitoring + routine postoperative follow-up |
Primary outcome
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Time frame: Up to 60 months.
Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis
Specificity of postoperative ctDNA in monitoring recurrence and metastasis
Time frame: Up to 60 months.
Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
Time frame: Up to 60 months.
True positive+True negative/sample size
Secondary resection rate
Time frame: Up to 60 months.
The rate of R0 resection for recurrence or metastasis after surgery of the primary
5 secondary outcomes
ctDNA-disease free survival (DFS)
Time frame: Under ctDNA monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
CT-DFS
Time frame: Under imaging monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
△DFS
Time frame: Up to 60 months.
overall survival (OS)
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.
ctDNA clearance rate
Time frame: Up to 60 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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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. This study is not recruiting at the moment.
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 dynamic monitoring in people with Stage III Colorectal Cancer and Circulating Tumor DNA, run by Fudan University 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junjie Peng, MD, PhD (86-18017317122, pengjj67@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis (time frame: Up to 60 months.). The study lists 4 primary outcomes in all. 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 Dec 2021.