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

Inclusion Criteria13

Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions:
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.
No prior radiotherapy to the lungs.
RECIST 1.1 criteria: The patient must have measurable lesions, defined as at least one nodal lesion with a longest diameter \> 1.5 cm, or at least one nodal lesion \> 1 cm with an accurately measurable pendulous diameter.
ECOG performance status: ≤ 2 (Eastern Cooperative Oncology Group general condition score).
The patient's expected survival must be ≥ 3 months.
Adequate hematologic function: Absolute neutrophil count ≥ 1.6 x 10⁹/L, with no growth factor support for at least 7 days prior to testing.
Normal organ function: The patient must be able to tolerate at least one of the local destructive treatments, as assessed by the corresponding department's physician, based on normal hepatic, renal, pulmonary, and cardiac function.
Reproductive age: Female patients of childbearing potential must agree to use a reliable method of contraception with their partner from the time of informed consent until 1 year after treatment completion.
The patient must have voluntarily provided informed consent to participate in the study.

Exclusion Criteria14

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.
Liver or kidney dysfunction: Alanine aminotransferase (ALT) \> 3 times the upper limit of normal; Aspartate aminotransferase (AST) \> 3 times the upper limit of normal; Total bilirubin (TBIL) \> 2 times the upper limit of normal; Serum creatinine \> 1.5 times the upper limit of normal.
Elevated tumor marker: CEA ≥ 50 ng/mL.
Serious medical conditions that may interfere with the study (e.g., uncontrolled diabetes, gastric ulcers, severe cardiopulmonary diseases), at the discretion of the researchers.
Severe or uncontrolled infections.
Active autoimmune disease.
Clinically significant central nervous system dysfunction.
Recent major surgery (excluding lymph node biopsy) within the last 30 days.
Pregnant or breastfeeding women of childbearing age who are not using contraception.
Drug allergy to study treatments.
Other reasons, as determined by the researchers, that make the patient unsuitable for participation.

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.