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Can aggressive tumor removal boost survival in Multi-Organ colorectal cancer?

NCT ID NCT01792934

Disease control Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial asks whether adding maximal tumor debulking—removing or destroying as many metastases as possible through surgery, heat ablation, chemo-embolization, or targeted radiation—to standard chemotherapy improves overall survival in people with colorectal cancer that has spread to multiple organs. Participants are randomly assigned to receive either chemotherapy alone or chemotherapy plus these additional local treatments. The study tracks survival, progression-free survival, and safety to see if the more aggressive approach offers a meaningful benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Combination of chemotherapy (XELOX or FOLFOX, with optional bevacizumab) plus maximal tumor debulking (surgery, RFA, TACE, or SBRT)
What this could lead to
If successful, this approach could extend survival for people with colorectal cancer that has spread to multiple organs, offering a more aggressive treatment strategy.
What could go wrong
The trial is early and the added procedures carry risks like complications from surgery or radiation. It is unclear if the benefits will outweigh these risks for all patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 478 people

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

Started

May 2013

Expected to finish

May 2028

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 years and older

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: * Histological or cytological documentation of cancer is required. * Indication for first line palliative systemic treatment for metastatic colorectal cancer (mCRC). * Patients with CRC metastases in (the primary tumor is excluded as metastatic site) * ≥ 2 different organs if at least \>1 extra-hepatic metastases or * ≥ 2 different organs including \>5 hepatic metastases not located to one lobe or * ≥ 2 different organs including either a positive para-aortal lymph nodes or celiac lymph nodes or adrenal metastases or pleural carcinomatosis or peritoneal carcinomatosis * Feasible radical tumor debulking. Incomplete tumor debulking is allowed only if at least 80% of metastases can be treated. * To meet the inclusion criteria a cytological analysis should be performed in case of any uncertainty about the presence of a lesion e.g. a false positive or false negative result on imaging. * Age ≥ 18 years. * WHO performance status 0 - 1. * Life expectancy of at least 12 weeks. * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * Hemoglobin ≥ 5.6 mmol/L; * Absolute neutrophil count (ANC) ≥ 1,500/mm3; * Platelet count ≥ 100\*109/l; * Total bilirubin ≤ 1.5 times the upper limit of normal; * ALT and AST ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for subjects with liver involvement of their cancer); * Albumin \> 30 g/l; * Serum creatinine ≤ 1.5 x upper limit of normal or a MDRD ≥ 50 ml/min; * Prothrombin time or INR \< 1.5 x ULN, unless coumarin derivates are used. Due to interactions with capecitabine, all patients using coumarin derivates will be treated with LMWH instead. * Activated partial thromboplastin time \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician). * Written informed consent. Exclusion Criteria: * Prior (neo-)adjuvant chemotherapy for \< 6 months after last treatment and first detection of extra-hepatic metastases, except for neoadjuvant capecitabine in the context of chemoradiation for rectal carcinoma. * Candidates for HIPEC. * Patients with liver metastases only * Evidence of brain metastases. * History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with other malignancies are eligible if they have remained disease free for at least 5 years.- History of cardiac disease: * Congestive heart failure \>NYHA class 2; * Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening); * Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). * Uncontrolled hypertension. Blood pressure must be ≤160/95 mm Hg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 3 separate measurements on at least 2 separate days. * Uncontrolled infections (\> grade 2 NCI-CTC version 4.0). * Pregnant or breast-feeding women. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) or intrauterine device during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. * Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug. * Concomitant use of dexamethasone, anticonvulsants and anti-arrhythmic drugs other than digoxin or beta blockers. * Severe allergy for contrast media not controlled with premedication. * Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results. * Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

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Conditions

The condition(s) this trial relates to.

colorectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multi-organ metastatic colorectal cancer

Contacts and locations

Locations

  • Admiraal de Ruyter Hospital

    Flushing, Netherlands

  • Albert Schweizer ziekenhuis

    Dordrecht, Netherlands

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Amstelveen Ziekenhuis

    Amstelveen, Netherlands

  • Antoni van Leeuwenhoek

    Amsterdam, Netherlands

  • Bravis ziekenhuis

    Roosendaal, Netherlands

  • Deventer Ziekenhuis

    Deventer, Netherlands

  • Dijklander

    Hoorn, Netherlands

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg, Netherlands

  • Erasmus University Medical Center

    Rotterdam, NL-3075 EA, Netherlands

  • Franciscus Gasthuis

    Rotterdam, Netherlands

  • Gelre

    Apeldoorn, Netherlands

  • IJsselland ziekenhuis

    Rotterdam, Netherlands

  • Isala Klinieken

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Maasstadziekenhuis

    Rotterdam, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, Netherlands

  • Meander Medisch Centrum

    Amersfoort, Netherlands

  • Medisch Centrum Haaglanden

    The Hague, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Noordwest Ziekenhuis Groep

    Alkmaar, Netherlands

  • Radboud University Medical Center

    Nijmegen, Netherlands

  • Sint Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • University College London Hospital

    London, United Kingdom

  • University Hospital Southampton

    Southampton, United Kingdom

  • VU Medical Center

    Amsterdam, NL-1081 HV, Netherlands

  • Zaans Medisch Centrum

    Zaandam, Netherlands

  • Ziekenhuisgroep Twente

    Almelo, Netherlands