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| ID | Type | Description | Link |
|---|---|---|---|
| U25A20115 | Other Grant/Funding Number | National Natural Science Foundation of China |
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This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up Group | No Intervention | In the follow-up group, patients with stage I and low-risk stage II CRC will not receive adjuvant therapy after surgery and will undergo ctDNA assessments at 3 and 6 months postoperatively. | |
| Single-agent chemotherapy group | Experimental | Patients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Patients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's 2-year Progression-Free Survival | Two-year Progression-Free Survival (PFS) is defined as the proportion of patients who remain alive without evidence of disease progression or recurrence within 24 months from the date of surgery (or randomization, as specified in the protocol). Disease progression is determined according to radiologic, clinical, or pathological criteria. | Two-year Progression-Free Survival |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA-clearance Rate | ctDNA clearance rate is defined as the proportion of patients with detectable circulating tumor DNA (ctDNA) at baseline who achieve conversion to undetectable ctDNA at a predefined post-treatment time point, as assessed by the specified ctDNA assay. | 3 month and 6 month after surgery |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoxiang Cai | Contact | 86-18017312703 | gxcaifuscc@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |