Clinical trial · Interventional
ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer (Stage II &Amp;Amp;Amp; III) | Malignant Colon Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-month adjuvant chemotherapy with 5-FU monotherapy | Drug | — | UNRESOLVED |
| XELOX intensive treatment group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Arm-A
- description
- Patients with negative ctDNA;Observation and follow-up
- type
- EXPERIMENTAL
- label
- Arm-B
- description
- Patients with negative ctDNA;6-month adjuvant chemotherapy with 5-FU monotherapy
- interventionNames
- Drug: 6-month adjuvant chemotherapy with 5-FU monotherapy
- type
- EXPERIMENTAL
- label
- Arm-C
- description
- Patients with positive ctDNA; 6-month adjuvant chemotherapy with 5-FU monotherapy
- interventionNames
- Drug: 6-month adjuvant chemotherapy with 5-FU monotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 70-80, both male and female are eligible; 2. Patients with histopathologically confirmed stage II high-risk or stage III colon cancer; 3. Patients with an ECOG score of ≤2; 4. Patients who are required to undergo tissue genetic testing; 5. Subjects who voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits. Exclusion Criteria: 1. 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. 2. Patients who have had a history of malignant tumors within 5 years. 3. 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). 4. Patients suffering from severe mental illnesses. 5. Patients who have participated in other clinical trials within 30 days prior to screening. 6. Patients who are unable to undergo adjuvant chemotherapy.
References
Publications (13)
- RESULTBadia-Ramentol J, Linares J, Gomez-Llonin A, Calon A. Minimal Residual Disease, Metastasis and Immunity. Biomolecules. 2021 Jan 20;11(2):130. doi: 10.3390/biom11020130. PMID 33498251
- RESULTDasari A, Morris VK, Allegra CJ, Atreya C, Benson AB 3rd, Boland P, Chung K, Copur MS, Corcoran RB, Deming DA, Dwyer A, Diehn M, Eng C, George TJ, Gollub MJ, Goodwin RA, Hamilton SR, Hechtman JF, Hochster H, Hong TS, Innocenti F, Iqbal A, Jacobs SA, Kennecke HF, Lee JJ, Lieu CH, Lenz HJ, Lindwasser OW, Montagut C, Odisio B, Ou FS, Porter L, Raghav K, Schrag D, Scott AJ, Shi Q, Strickler JH, Venook A, Yaeger R, Yothers G, You YN, Zell JA, Kopetz S. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020 Dec;17(12):757-770. doi: 10.1038/s41571-020-0392-0. Epub 2020 Jul 6. PMID 32632268
- RESULTUeda Y, Shiraishi N, Kawasaki T, Akagi T, Ninomiya S, Shiroshita H, Etoh T, Inomata M. Short- and long-term outcomes of laparoscopic surgery for colorectal cancer in the elderly aged over 80 years old versus non-elderly: a retrospective cohort study. BMC Geriatr. 2020 Nov 4;20(1):445. doi: 10.1186/s12877-020-01779-2. PMID 33148215
- RESULTArgiles G, Tabernero J, Labianca R, Hochhauser D, Salazar R, Iveson T, Laurent-Puig P, Quirke P, Yoshino T, Taieb J, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Localised colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1291-1305. doi: 10.1016/j.annonc.2020.06.022. Epub 2020 Jul 20. No abstract available. PMID 32702383
- RESULTSiegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8. PMID 31912902
- RESULTHutchins LF, Unger JM, Crowley JJ, Coltman CA Jr, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999 Dec 30;341(27):2061-7. doi: 10.1056/NEJM199912303412706.