Actively Recruiting
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer
Led by Peking University Cancer Hospital & Institute · Updated on 2022-09-07
2684
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The IDEA study classified stage III colon cancer into low-risk (T1-3/N1) and high-risk patients (T4 or N2) according to TNM stage. The results showed that for some low-risk patients, chemotherapy could be reduced without survival loss. In recent years, circulating tumor DNA had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. Postoperative ctDNA is also considered as a marker of increased risk of recurrence for stage I-III colon cancer and can provide predictive information for decision making on adjuvant treatment. The results of GERCOR-PRODIGE, concomitant study of IDEA-FRANCE, showed that in the high-risk group, the patients with ctDNA positive and receiving adjuvant chemotherapy for 6 months had similar prognosis as the patients with ctDNA negative and receiving chemotherapy for 3 months; in the low-risk group, the patients with ctDNA positive but receiving chemotherapy for 3 months had worst prognosis, and the prognosis of patients with ctDNA negative chemotherapy for 3 months and 6 months and ctDNA positive chemotherapy for 6 months were similar. This indicates that risk stratification can be further performed according to the results of ctDNA after clinical pathological staging. Pathological staging is still an important decision-making factor for chemotherapy. It is not reliable to the chemotherapy decision making just based on ctDNA and abandoning clinical staging. Therefore, a prospective, multicenter, open-label, randomized controlled clinical trial was designed aimed to investigate circulating tumor DNA guided adjuvant chemotherapy for colon cancer. In this study, all the patients are divided into high-risk group and low-risk group according to the postoperative pathology. Patients in each group were randomized to different treatment schedule according to the results of ctDNA.
CONDITIONS
Official Title
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Colon adenocarcinoma confirmed by pathology, including various types such as tubular, papillary, mucinous, and signet ring cell carcinoma
- Postoperative pathological stage II with high-risk factors or stage III colon cancer
- High-risk stage II defined by at least one of: T4 stage; fewer than 12 lymph nodes detected; poor differentiation (except MSI-H); presence of lymphovascular or perineural invasion; obstruction or perforation
- No distant metastasis found in preoperative imaging and surgery
- ECOG performance status 0 to 2
- MSS/pMMR and BRAF wild type status
- Chemotherapy started within 2 months after surgery
- Sufficient organ function
- Baseline blood and biochemical tests meet specified thresholds: hemoglobin ≥ 9.0 g/dl; absolute neutrophil count ≥ 1500/mm3; platelet count ≥ 100000/mm3; total bilirubin ≤ 1.5 times upper limit normal; liver enzymes ≤ 2.5 times upper limit normal; creatinine ≤ 1.5 times upper limit normal
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Received chemotherapy, radiotherapy, or immunotherapy before surgery
- History of malignant tumor within past 5 years except fully cured cervical carcinoma in situ or certain skin cancers
- Pregnant women
- Serious mental illness
- Poor physical condition making chemotherapy difficult
- Unable to understand study conditions and objectives
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking university cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
P
Pengju Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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