NCT06609551RecruitingPhase 3
ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study
Source: ClinicalTrials.gov · Last updated 24 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection. The main questions it aims to answer are: Can ctDNA detection effectively guide the assessment of disease-free survival in elderly patients with high-risk stage II and stage III colon cancer? What is the correlation between postoperative ctDNA status and patient imaging as well as prognosis in elderly patients? Secondary objectives include: Evaluating the correlation between postoperative ctDNA status and patient imaging, as well as prognosis, in elderly patients. Analyzing the positive rate of postoperative ctDNA and the ctDNA clearance rate. Additionally, an exploratory objective of this study is to investigate recurrence models for postoperative patients. Participants will undergo ctDNA testing to assess their disease status and will be monitored for disease-free survival. Imaging studies will also be conducted to correlate with ctDNA findings. The study aims to gain a deeper understanding of the role of ctDNA in predicting prognosis and monitoring disease recurrence in elderly patients with colon cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 22 Sept 2024
- Start date
- 3 Jul 2024
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Zhejiang Cancer Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06609551
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 312
- From 3 Jul 2024 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with one or more severe concomitant systemic diseases that, in the investigator\'s opinion, would impair the patient\'s ability to complete the study.
- Patients who have participated in other clinical trials within 30 days prior to screening.
- Patients who are unable to undergo adjuvant chemotherapy.
Other illness
- Patients who have had a history of malignant tumors within 5 years.
- Any unstable systemic disease (including active infection, poorly controlled diabetes, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction within one year, severe arrhythmia requiring medical treatment, liver, kidney, or metabolic diseases).
- Patients suffering from severe mental illnesses.
Who the study is looking for
- Patients aged 70-80, both male and female are eligible;
- Patients with histopathologically confirmed stage II high-risk or stage III colon cancer;
- Patients with an ECOG score of ≤2;
- Patients who are required to undergo tissue genetic testing;
- Subjects who voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Age in the registry: 70 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.