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New treatment option for High-risk Stage II Colorectal Cancer
Official title Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer
ClinicalTrials.gov ID: NCT05954078
What this study is testing
What is mFOLFIRINOX adjuvant chemotherapy?
mFOLFIRINOX adjuvant chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high-risk stage ii colorectal cancer.
Also referred to as Oxaliplatin, Irinotecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colorectal cancer (CRC) is one of the most common gastrointestinal tumors. According to the latest cancer report, the incidence and mortality rates of CRC are both ranked top 5 among malignant tumors worldwide and continue to rise.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients who have been histopathologically diagnosed with colorectal adenocarcinoma;
- Patients who have undergone radical curative resection of the primary tumors;
- Patients with CRC of high-risk stage II and stage III based on final findings (UICC TNM Classification, 8th Edition);
- Patients who tested positive for ctDNA methylation at 5-7 days after surgery prior to enrollment;
- Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc.;
You likely can't join if
- Neoadjuvant therapy performed before operation;
- Blood transfusion performed during operation or within 2 weeks before operation;
- Incomplete baseline samples, including preoperative plasma samples and plasma samples 5-7 days after operation;
- 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;
- Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms;
See the full eligibility criteria
- Patients who have been histopathologically diagnosed with colorectal adenocarcinoma;
- Patients who have undergone radical curative resection of the primary tumors;
- Patients with CRC of high-risk stage II and stage III based on final findings (UICC TNM Classification, 8th Edition);
- Patients who tested positive for ctDNA methylation at 5-7 days after surgery prior to enrollment;
- Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc.;
- Patients aged ≥ 18 and ≤80 years old, regardless of gender;
- Patients with expected survival of more than 12 months;
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Patients who have no severe disorder in major organs (such as the bone marrow, heart, lungs, liver, and kidneys) and meet the following criteria: Neutrophil count ≥ 1,500/mm3, Platelet count ≥ 100,000/mm3, Hemoglobin ≥...
- Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0;
- Patients who voluntarily gave written consent to participate in the trial after receiving a thorough explanation of the trial before enrolling in the trial
- Neoadjuvant therapy performed before operation;
- Blood transfusion performed during operation or within 2 weeks before operation;
- Incomplete baseline samples, including preoperative plasma samples and plasma samples 5-7 days after operation;
- 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;
- 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...
- Significant impairment of important organ function;
- Other conditions in which the investigator believes that the patient should not participate in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.