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Trial Title:
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer
NCT ID:
NCT05529615
Condition:
Colon Cancer
Circulating Tumor DNA
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
chemotherapy
ctDNA
colon cancer
prognosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
detection of ctDNA
Description:
the ctDNA will be detected during the treatment and served as the andomization basis
Arm group label:
stage II with high risk and stage III with low risk（T1-3N1）
Arm group label:
stage III with high risk（T4 or N2 or both）
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 to 75
2. Colon adenocarcinoma confirmed by pathology (including high and high differentiated
tubular adenocarcinoma, papillary adenocarcinoma, low differentiated adenocarcinoma,
mucinous adenocarcinoma and signet ring cell carcinoma)
3. Postoperative pathology is stage II with high-risk factors or stage III;
High risk stage II refers to stage II colon cancer with at least one of the
following:
a) T4 stage; b) The number of lymph nodes detected was less than 12; c) Poor
differentiation (except MSI-H); d) Complicated with LVI or PNI；e) Complicated with
obstruction or perforation.
4. No distant metastasis was found in preoperative imaging examination and operation;
5. ECOG score: 0-2 points;
6. MSS/pMMR and BRAF wild type
7. Start time of chemotherapy is less than 2 months from the operation
8. Have sufficient organ functions;
9. The baseline blood routine and biochemical indexes of the subject meet the following
standards:
- hemoglobin ≥ 9.0 g / dl;
- absolute neutrophil count (ANC) ≥ 1500 / mm3;
- platelet count ≥ 100000 / mm3;
- total bilirubin ≤ 1.5 times the upper limit of normal value (ULN);
- glutamic pyruvic transaminase and glutamic oxalic transaminase ≤ 2.5 times ULN;
- creatinine ≤ 1.5 times ULN;
10. Patients or family members who can understand the study protocol and are willing to
participate in the study shall provide written informed consent.
Exclusion Criteria:
1. Receive chemotherapy, radiotherapy or immunotherapy before operation
2. History of malignant tumor in the past 5 years (except fully cured cervical
carcinoma in situ or basal cell carcinoma or squamous epithelial cell skin cancer)
3. Pregnant women
4. Serious mental illness
5. Those with poor physical condition and difficult to complete chemotherapy
6. Patients or family members cannot understand the conditions and objectives of this
study
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking university cancer hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Pengju Chen, M.D.
Phone:
+8601088196086
Email:
pengjuchen@163.com
Start date:
November 1, 2022
Completion date:
May 1, 2029
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05529615
