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Could a wait-and-see approach replace chemo for lung metastases in colorectal cancer?

NCT ID NCT06778382

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Department of Radiation Oncology, Shandong Cancer Hospital and Institute

    RECRUITING

    Jinan, Shandong, 0531, China

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