Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is one of the primary treatment options for CRC; however, postoperative recurrence remains a significant clinical challenge for both the medical community and patients. Postoperative chemotherapy, as an important adjuvant therapy, is widely used in CRC patients aiming to reduce the risk of recurrence. Despite extensive research on the efficacy of postoperative chemotherapy in CRC, the mechanisms of postoperative recurrence, predictive factors, and strategies to enhance chemotherapy effectiveness remain unclear. For colorectal cancer patients who have achieved NED (No Evidence of Disease), the decision to either reinitiate or change the systemic chemotherapy regimen for newly developed pulmonary oligometastases remains controversial. Local treatment options for diagnosing oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic treatment should be added after local treatment in patients who have achieved NED remains uncertain , and this issue requires urgent resolution.
The patient has achieved No Evidence of Disease (NED) after undergoing EMR, surgery, radiofrequency ablation, or radiotherapy.
NED has been maintained for ≥ 6 months.
The patient has not received chemotherapy, or has only received postoperative adjuvant chemotherapy or first-line systemic therapy.
Oligometastatic lung lesions (defined as 5 or fewer lesions) detected after ≥ 6 months of NED maintenance, eligible for destructive therapy.
First diagnosis of advanced colorectal cancer with metastatic disease.
Multiple lung metastases (> 5 lesions), liver metastasis, bone metastasis, or lymph node metastasis.
Lung metastases that are not amenable to radiotherapy, as determined by the investigator.
Previously received second-line or higher systemic treatment.
Single group
Oligometastasis Treatment
Combination productOligometastatic Radiotherapy Group: Patients will receive radiotherapy to lung lesions, with the lung metastases outlined as the Gross Tumor Volume (GTV). The prescribed dose will be based on a BED (Biologically Effective Dose) of 72-100 Gy, using either conventional split, macrodissected, or SBRT (Stereotactic Body Radiation Therapy) at the investigator's discretion. No systemic therapy will be administered. Oligometastatic Radiofrequency Ablation Group: For lesions suitable for radiofrequency ablation, this will be performed in consultation with the Department of Interventional Medicine, considering patient and family preferences. Systemic therapy will not be given. Oligometastatic Surgery Group: For lesions suitable for surgical resection, patients will undergo surgery after consultation with the Department of Surgery. No systemic therapy will be performed.
Time Without Systemic Therapy
The time interval between diagnosis or the completion of the current systemic treatment and the start of the next systemic therapy
Progression-Free Survival（PFS）
The time interval between enrollment and disease progression or death for patients in the intent-to-treat population, whichever occurred first. For those who did not progress at the time of withdrawal from the trial or whose time to disease progression was not recorded, the date of the last examination was used as the endpoint date
Time to Next Treatment (TTNT)
The time interval from the completion of the first SBRT/radiofrequency ablation/surgery to the initiation of the next anticancer treatment or death from any cause
Overall Response Rate (ORR)
Percentage of subjects in the protocol-eligible population and in the intent-to-treat population who achieved CR+PR after treatment
Disease Control Rate (DCR)
Percentage of subjects in the protocol-eligible population and in the intention-to-treat population who achieved CR+PR+SD after treatment
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