Could a wait-and-see approach replace chemo for lung metastases in colorectal cancer?
NCT ID NCT06778382
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at colorectal cancer patients whose disease is under control (no evidence of disease) but later develop a small number of lung tumors. Instead of starting chemotherapy right away, doctors will treat the lung spots with surgery or radiation and then watch closely. The goal is to see how long patients can go without needing chemotherapy again. About 22 adults will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions: 1. The patient has achieved No Evidence of Disease (NED) after undergoing EMR, surgery, radiofrequency ablation, or radiotherapy. 2. NED has been maintained for ≥ 6 months. 3. The patient has not received chemotherapy, or has only received postoperative adjuvant chemotherapy or first-line systemic therapy. 4. Oligometastatic lung lesions (defined as 5 or fewer lesions) detected after ≥ 6 months of NED maintenance, eligible for destructive therapy. 5. 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Radiation Oncology, Shandong Cancer Hospital and Institute
RECRUITINGJinan, Shandong, 0531, China
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Other studies related to the condition(s) this trial covers.
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