NCT05529615Recruiting
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 7 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2684 (estimated)
- First submitted
- 25 Aug 2022
- Start date
- 1 Nov 2022
- Primary completion date
- 1 May 2029
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT05529615
What you commit to
- Study type: Interventional
- Planned participants: 2684
- From 1 Nov 2022 to the primary completion date, 1 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receive chemotherapy, radiotherapy or immunotherapy before operation
Other illness
- 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)
- Serious mental illness
- Those with poor physical condition and difficult to complete chemotherapy
- Patients or family members cannot understand the conditions and objectives of this study
Other
- Pregnant women
Who the study is looking for
- Age: 18 to 75
- Colon adenocarcinoma confirmed by pathology (including high and high differentiated tubular adenocarcinoma, papillary adenocarcinoma, low differentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma)
- 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:
- 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.
- No distant metastasis was found in preoperative imaging examination and operation;
- ECOG score: 0-2 points;
- MSS/pMMR and BRAF wild type
- Start time of chemotherapy is less than 2 months from the operation
- Have sufficient organ functions;
- 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;
- Patients or family members who can understand the study protocol and are willing to participate in the study shall provide written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.