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.
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is a primary treatment option; however, postoperative recurrence remains a significant challenge. Postoperative chemotherapy is commonly used as an adjuvant treatment to reduce recurrence risk, but the mechanisms of recurrence, predictive factors, and strategies to enhance chemotherapy efficacy remain unclear.For CRC patients who have achieved No Evidence of Disease (NED), the decision to reinitiate or modify systemic chemotherapy for newly developed pulmonary oligometastases is still debated. Local treatment options for pulmonary oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic therapy should follow local treatment in NED patients is uncertain.This issue is actively debated in multidisciplinary team (MDT) consultations both in our hospital and across the country. Some experts argue that pulmonary oligometastases signify disease progression, requiring systemic treatment, while others suggest that these metastases may not indicate high malignancy and that observation, with possible delayed systemic treatment, could be sufficient.This study will include CRC patients who have achieved NED for at least six months and then develop pulmonary oligometastases, treated exclusively with destructive local therapies (surgery, radiotherapy, or ablation) without systemic therapy. The study will assess the timing of transitioning to the next line of systemic therapy through imaging and ctDNA monitoring.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Oligometastatic 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.
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China
RECRUITINGTime Without Systemic Therapy
The time interval between diagnosis or the completion of the current systemic treatment and the start of the next systemic therapy
Time frame: 2 years
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 frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
Complete Response Rate (CRR)
Percentage of subjects achieving CR after treatment in the protocol-eligible population as well as in the intent-to-treat population
Time frame: 2 years
Duration of Response (DOR)
The time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause
Time frame: 2 years
Overall Survival (OS)
The time interval between enrollment and death for patients in the intent-to-treat (ITT) population. If the patient continues to be alive or his/her fate is unknown, the date of death will be the most recent point in time at which the patient was known to be alive
Time frame: 2 years
Incidence of Adverse Effects
Evaluation of toxicity according to NCI CTCAE 5.0 criteria
Time frame: 2 years
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