Clinical Research Directory
Browse clinical research sites, groups, and studies.
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
Sponsor: Shandong Cancer Hospital and Institute
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.
Official title: Deferred Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After NED in Colorectal Cancer: A Phase II, Single-Arm Clinical Trail.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2024-06-24
Completion Date
2025-11-01
Last Updated
2025-10-07
Healthy Volunteers
No
Conditions
Interventions
Oligometastasis 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.
Locations (1)
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China