CtDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: a Single-center, Randomized, Controlled Study
NCT ID: NCT06609551
Last Updated: 2024-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
312 participants
INTERVENTIONAL
2024-07-03
2034-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study
NCT05161585
Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
NCT03958435
Investigation of the Value of ctDNA in Diagnosis, Treatment, and Surveillance of Surgically Resectable Colorectal Cancer
NCT03038217
CtDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial)
NCT06242418
ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation
NCT05536089
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Screening Phase Complete the routine pre-enrollment evaluation of subjects, such as medical history, pathological staging, and treatment history. Researchers will assess whether subjects meet the enrollment criteria (see inclusion and exclusion criteria). For subjects who meet the enrollment criteria, the attending physician will inform the subjects and their families, explaining the purpose, advantages, disadvantages, and the entire research process of this clinical trial. They will seek the opinions of the subjects and their families, and obtain signed informed consent from the subjects.
Researchers need to collect baseline postoperative tissue samples for detection, which will be used for the customization of personalized probes for subsequent blood tests.
2. Adjuvant Therapy/Follow-up Phase Elderly colorectal cancer patients who meet the inclusion and exclusion criteria will undergo ctDNA-MRD testing after surgery. ctDNA-negative patients will be randomly divided into two groups in a 1:1 ratio: 1) Observation and follow-up; 2) 6-month adjuvant chemotherapy with 5-FU monotherapy. Patients who test positive for ctDNA will be randomly assigned in a 1:1 ratio to receive: 1) 6 months of 5-FU monotherapy; 2) XELOX intensive treatment group. The follow-up strategy is the same for all four groups, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA) until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again half a year after surgery.
3. Management Measures for Subjects with Disease Progression If a patient experiences disease progression, efforts should be made to continue tracking and recording the patient\'s subsequent anti-tumor treatment and survival outcomes, including local and/or systemic therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm-A
Patients with negative ctDNA；Observation and follow-up
No interventions assigned to this group
Arm-B
Patients with negative ctDNA;6-month adjuvant chemotherapy with 5-FU monotherapy
6-month adjuvant chemotherapy with 5-FU monotherapy
6 months of adjuvant chemotherapy with 5-FU monotherapy. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.
Arm-C
Patients with positive ctDNA; 6-month adjuvant chemotherapy with 5-FU monotherapy
6-month adjuvant chemotherapy with 5-FU monotherapy
6 months of adjuvant chemotherapy with 5-FU monotherapy. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.
Arm-D
Patients with positive ctDNA; XELOX intensive treatment group
XELOX intensive treatment group
XELOX intensive treatment group. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
6-month adjuvant chemotherapy with 5-FU monotherapy
6 months of adjuvant chemotherapy with 5-FU monotherapy. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.
XELOX intensive treatment group
XELOX intensive treatment group. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
70 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhejiang Cancer Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhu Yuping
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Badia-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.
Dasari 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.
Ueda 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.
Argiles 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: [email protected]. 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.
Siegel 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.
Hutchins 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.
Kim JH. Chemotherapy for colorectal cancer in the elderly. World J Gastroenterol. 2015 May 7;21(17):5158-66. doi: 10.3748/wjg.v21.i17.5158.
Herrera AP, Snipes SA, King DW, Torres-Vigil I, Goldberg DS, Weinberg AD. Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S105-12. doi: 10.2105/AJPH.2009.162982. Epub 2010 Feb 10.
Waldron RP, Donovan IA, Drumm J, Mottram SN, Tedman S. Emergency presentation and mortality from colorectal cancer in the elderly. Br J Surg. 1986 Mar;73(3):214-6. doi: 10.1002/bjs.1800730320.
Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.
Zheng R, Zhang S, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent. 2022 Feb 27;2(1):1-9. doi: 10.1016/j.jncc.2022.02.002. eCollection 2022 Mar.
Kurniali PC, Hrinczenko B, Al-Janadi A. Management of locally advanced and metastatic colon cancer in elderly patients. World J Gastroenterol. 2014 Feb 28;20(8):1910-22. doi: 10.3748/wjg.v20.i8.1910.
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-2024-380
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.