RecruitingPhase 2NCT06778382

Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.

Deferred Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After NED in Colorectal Cancer： A Phase II, Single-Arm Clinical Trail.

Sponsor

Shandong Cancer Hospital and Institute

Enrollment

22 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasms Malignant

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether it is safe and effective to delay or watch-and-wait on systemic chemotherapy after colorectal cancer has spread to the lungs in small amounts (oligometastases) and has been treated with local procedures like surgery or radiation. Researchers want to know if treating only the lung spots — without immediately starting full-body chemotherapy — is a valid strategy. **You may be eligible if...** - You have been diagnosed with colorectal cancer - Your cancer previously showed no evidence of disease (NED) for at least 6 months after treatment - You have developed 5 or fewer new lung lesions that can be treated with local therapy (surgery, radiation, or ablation) - You have not had prior lung radiation therapy - You have either had no chemotherapy before, or only standard adjuvant or first-line chemotherapy **You may NOT be eligible if...** - You have cancer that has spread beyond the lungs or that cannot be treated locally - You have more than 5 lung lesions - You have had more than one prior line of chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTOligometastasis Treatment

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.