Actively Recruiting

Phase 3
Age: 70Years - 80Years
All Genders
NCT06609551

ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study

Led by Zhejiang Cancer Hospital · Updated on 2024-09-24

312

Participants Needed

1

Research Sites

547 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study

Who Can Participate

Age: 70Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 70 to 80 years, both male and female
  • Histopathologically confirmed stage II high-risk or stage III colon cancer
  • ECOG performance score of 2 or less
  • Required to undergo tissue genetic testing
  • Willing to voluntarily participate, sign informed consent, comply with study procedures, and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Presence of one or more severe systemic diseases that may prevent study completion
  • History of malignant tumors within the past 5 years
  • Unstable systemic diseases including active infection, poorly controlled diabetes or hypertension, unstable angina, recent myocardial infarction, severe arrhythmia, or liver, kidney, or metabolic diseases
  • Severe mental illness
  • Participation in another clinical trial within 30 days before screening
  • Inability to undergo adjuvant chemotherapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

Y

Yuping Zhu, M.D.

CONTACT

Y

Yibo Cai, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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