Metastatic Colorectal CancerPhase 2SIRIUSNCT05375708
Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer Up to 10 Metastatic Sites
A Phase 2 study testing Stereotactic body radiation therapy (SBRT) and Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.) in people with Metastatic Colorectal Cancer and Oligometastatic Disease, run by UMC Utrecht at 4 sites in Netherlands.
Trial summary
A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Oligometastatic Disease
- What is being tested?
- Stereotactic body radiation therapy (SBRT) and Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 Dec 2025to 1 Jun 2034
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered in the prospective Dutch colorectal cancer cohort (PLCRC)
- Intention at start of palliative systemic therapy to receive six maximum tolerated dose (MTD) cycles of CAPOX-B or eight MTD cycles of FOLFOX-B or FOLFOXIRI-B.
- Ten or less metastases as determined by the university medical center Utrecht (UMCU) central review
- Stable disease or partial response after initial chemotherapy according to RECIST 1.1 criteria.
- Expected adequacy of follow-up
- World Health organization (WHO) performance status 0-1
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- Life expectancy >12 weeks
- Adequate organ functions at start of initial therapy, as determined by normal bone marrow function (Hb≥6.0 mmol/L, absolute neutrophil count ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L), renal function (serum creatinine ≤ 1.5x upper limit of normal (ULN) and creatinine clearance, Cockcroft formula, ≥30 ml/min) and liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases)
- Written informed consent (SIRIUS)
Who cannot join
- Less than three cycles of CAPOX-B or four cycles of FOLFOX-B or FOLFOXIRI-B (dose reductions allowed).
- More than six cycles of CAPOX-B or eight cycles of FOLFOX-B of FOLFOXIRI-B.
- Possible treatment with curative intent according to local tumor board
- Substantial overlap with a previously treated radiation volume. Previous radiotherapy is allowed as long as the composite plan meets dose constraints herein.
- Not amenable for radiotherapy (e.g. peritonitis carcinomatosa)
- Previous systemic treatment for metastatic disease; prior adjuvant treatment for stage II/III colorectal cancer when given >6 months before the start of initial systemic treatment is allowed.
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- Serious comorbidity or any other condition preventing the safe administration of treatment (including both systemic treatment and radiation)
- Pregnant or lactating women
- Other malignancy interfering with prognosis
- Any concomitant experimental treatment.
- Contra-indication MR-LINAC (pacemaker or implantable cardioverter-defibrillator)
- Microsatellite instability or deficient mismatch repair tumor
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Meander Medical Centre
Amersfoort, Utrecht, 3813TZ
St. Antonius
Utrecht, Utrecht, 3543AZ
Diakonessenhuis
Utrecht, Utrecht, 3582KE
UMC Utrecht
Utrecht, Utrecht, 3584CX
About this study
Official title: A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer
A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.
Read the detailed description
The addition of stereotactic body radiation therapy (SBRT) to metastases in a limited unresectable metastatic setting might improve progression-free survival (PFS). The success of the addition of local treatments in mCRC patients depends largely on: control of microscopic disease, diagnostic accuracy of macroscopic disease and effective treatment of all detected metastases with limited additional toxicity to surrounding tissues. Until shortly, the use of SBRT was possible to a limited number of locations due to target movement or toxicity to surrounding radiosensitive structures. With the introduction of MRI-guided radiotherapy these limitations have been largely reduced due to the possibility to make a daily new treatment plan based on MRI-visualized anatomy. This allows the use of smaller margins for uncertainty with less healthy tissues in the radiation field. Thereby, a broader application of SBRT to add local control to metastases became possible.
This study is an open-label, multicenter, randomized phase II screening trial assessing the impact of SBRT in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with mCRC and ≤10 metastases with no option of local treatment with curative intent and with stable disease or partial response after treatment of CAPOX-B, FOLFOX-B or FOLFOXIRI-B.
- Being tested
- Stereotactic body radiation therapy (SBRT), Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.)
- Keywords
- Metastatic colorectal cancer, Image guided radiation, MR guided therapy, Oligometastatic / polymetastatic cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapy (SBRT)Radiation
Patients will receive a single fraction of 15 Gy to each of the macroscopic tumor sites including the primary tumor if still in situ. All lesions are treated. The treatment will be delivered in an image-guided way, either on a conventional linear accelerator (LINAC) or a MR-LINAC, whichever has the best targeting according to the treating radiation oncologist.
Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.)Drug
CAP + bevacizumab (following CAPOX-B) Bevacizumab 7.5mg/kg i.v. on day 1 and 1250 mg/m2 of capecitabine, orally twice daily on days 1-14 if age is <70 years and 1000 mg/m2 of capecitabine, orally twice daily on days 1-14 if age is higher than 70 years. CAP + bevacizumab is repeated every three weeks.
5-FU/LV + bevacizumab (following FOLFOX-B) Bevacizumab 5.0mg/kg i.v. together with leucovorin 400 mg/m2 i.v. bolus 5FU 400 mg/m2 all on day 1. Followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours. 5-FU + bevacizumab is repeated every two weeks.
5-FU/LV + bevacizumab (following FOLFOXIRI-B) Bevacizumab 5.0mg/kg i.v. together with leucovorin 400 mg/m2 i.v. all on day 1. Followed by continuous infusion of 5-fluorouracil 3200 mg/m2 in 46 hours. 5-FU + bevacizumab is repeated every two weeks.
When S1 is used a replacement for fluoropyrimidine therapy it is administered in a dose of 30mg/m2 twice daily on days 1-14. S1 is repeated every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Systemic maintenance therapy | Active comparator | Not described Receives: Drug: Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.) |
| Systemic maintenance therapy in combination with stereotactic body radiation therapy (SBRT) | Experimental | Not described Receives: Radiation: Stereotactic body radiation therapy (SBRT); Drug: Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Defined as time from randomization to progression of disease or death, whichever occurs first. Progression of disease is based on tumor response as observed on radiographic imaging according to the RECIST 1.1 criteria.
Measured: Through study completion, an average of 24 months
Secondary outcomes (11)
Accrual rate as assessed by the number of patients included in the study compared to the expected accrual rate.
We expect to include 93 patients in 24 months. The expected accrual rate in this study is, therefore, around 4 patients per month. Information for the accrual rate is used from the total accrual rate, the accrual rate in each study center and screening failures.
Measured: Through study completion, an average of 24 months
Treatment success rate
Dose intensity of SBRT based on the number of patients that receive more than 90% of the planned dose on all lesions in 95% of the planned target volume (PTV).
Measured: Through study completion, an average of 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
This will be based on the number of patients with SBRT related toxicity, defined as newly developed grade 2 toxicity of specific interest and grade 3-4 toxicity since randomization according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured: Through study completion, an average of 24 months
Overall survival
Defined as time from randomization to death of any cause.
Measured: Up to 72 months
Comparing changes on health-related quality of life based on summary score of Quality of Life Questionnaire-Core30 (QLQ-C30) from baseline and 3-monthly timepoints.
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score is better level of functioning.
Measured: Through study completion, an average of 24 months
Comparing changes on health-related quality of life based on summary score of Quality of Life Questionnaire-Core29 (QLQ-C29) from baseline and 3-monthly timepoints.
EORTC QLQ-C30 is a 29-item questionnaire to assess the overall quality of life in cancer patients. All questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score is better level of functioning.
Measured: Through study completion, an average of 24 months
Comparing changes from health-related quality of life based on summary score of Multidimensional Fatigue Inventory (MFI-20) from baseline and 3-monthly timepoints.
MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).
Measured: Through study completion, an average of 24 months
Pattern of reccurence according to RECIST 1.1: New metastatic lesions, progression of existing lesions or a combination.
New metastatic lesions, progression of existing lesions or a combination of both new metastatic lesions and progression of existing lesions based on radiographic imaging according to RECIST 1.1
Measured: Through study completion, an average of 24 months
Time to treatment failure
Defined as the time of randomization to failure of treatment. If radiologically visible metastatic lesions before systemic therapy are no longer visible at randomization (vanishing lesions) and recurrence of vanishing lesions occurs in patients in the experimental arm without progression of other lesions, this is not yet determined as failure of treatment; additional local therapy is highly encouraged on these lesions (to the discretion of the local investigator). When progression of existing lesions or new lesions occur, it will be determined as failure of treatment.
Measured: Through study completion, an average of 24 months
Tumor response
Based on radiographic imaging according to the RECIST 1.1 criteria.
Measured: Through study completion, an average of 24 months
Depth of response
Based on radiographic imaging
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2034 (estimated)
Why it stopped: Pilot study findings pointed to a overhaul in study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guus Bol, UMC Utrecht
- Investigators
- Guus Bol, Dr., Principal investigator, UMC UtrechtMartijn Intven, Dr., Principal investigator, UMC UtrechtMiriam Koopman, Prof. Dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375708
- Sponsor's protocol ID
- NL76444.041.21
- Acronym
- SIRIUS
- Status last verified
- Mar 2025
- First submitted
- 5 Apr 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05375708
- Acronym / sponsor ID
- SIRIUS / NL76444.041.21
- Keywords
- Metastatic colorectal cancer, Image guided radiation, MR guided therapy, Oligometastatic / polymetastatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pilot study findings pointed to a overhaul in study design
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2034 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.
Detailed description
The addition of stereotactic body radiation therapy (SBRT) to metastases in a limited unresectable metastatic setting might improve progression-free survival (PFS). The success of the addition of local treatments in mCRC patients depends largely on: control of microscopic disease, diagnostic accuracy of macroscopic disease and effective treatment of all detected metastases with limited additional toxicity to surrounding tissues. Until shortly, the use of SBRT was possible to a limited number of locations due to target movement or toxicity to surrounding radiosensitive structures. With the introduction of MRI-guided radiotherapy these limitations have been largely reduced due to the possibility to make a daily new treatment plan based on MRI-visualized anatomy. This allows the use of smaller margins for uncertainty with less healthy tissues in the radiation field. Thereby, a broader application of SBRT to add local control to metastases became possible.
This study is an open-label, multicenter, randomized phase II screening trial assessing the impact of SBRT in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with mCRC and ≤10 metastases with no option of local treatment with curative intent and with stable disease or partial response after treatment of CAPOX-B, FOLFOX-B or FOLFOXIRI-B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic maintenance therapy | Active comparator | Drug: Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.) |
| Systemic maintenance therapy in combination with stereotactic body radiation therapy (SBRT) | Experimental | Radiation: Stereotactic body radiation therapy (SBRT), Drug: Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Registered in the prospective Dutch colorectal cancer cohort (PLCRC)
- Intention at start of palliative systemic therapy to receive six maximum tolerated dose (MTD) cycles of CAPOX-B or eight MTD cycles of FOLFOX-B or FOLFOXIRI-B.
- Ten or less metastases as determined by the university medical center Utrecht (UMCU) central review
- Stable disease or partial response after initial chemotherapy according to RECIST 1.1 criteria.
- Expected adequacy of follow-up
Key exclusion criteria (12 listed)
- Less than three cycles of CAPOX-B or four cycles of FOLFOX-B or FOLFOXIRI-B (dose reductions allowed).
- More than six cycles of CAPOX-B or eight cycles of FOLFOX-B of FOLFOXIRI-B.
- Possible treatment with curative intent according to local tumor board
- Substantial overlap with a previously treated radiation volume. Previous radiotherapy is allowed as long as the composite plan meets dose constraints herein.
- Not amenable for radiotherapy (e.g. peritonitis carcinomatosa)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiation therapy (SBRT)Patients will receive a single fraction of 15 Gy to each of the macroscopic tumor sites including the primary tumor if still in situ. All lesions are treated. The treatment will be delivered in an image-guided way, either on a conventional linear accelerator (LINAC) or a MR-LINAC, whichever has the best targeting according to the treating radiation oncologist. | Radiation | Systemic maintenance therapy in combination with stereotactic body radiation therapy (SBRT) |
| Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.)CAP + bevacizumab (following CAPOX-B) Bevacizumab 7.5mg/kg i.v. on day 1 and 1250 mg/m2 of capecitabine, orally twice daily on days 1-14 if age is <70 years and 1000 mg/m2 of capecitabine, orally twice daily on days 1-14 if age is higher than 70 years. CAP + bevacizumab is repeated every three weeks. 5-FU/LV + bevacizumab (following FOLFOX-B) Bevacizumab 5.0mg/kg i.v. together with leucovorin 400 mg/m2 i.v. bolus 5FU 400 mg/m2 all on day 1. Followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours. 5-FU + bevacizumab is repeated every two weeks. 5-FU/LV + bevacizumab (following FOLFOXIRI-B) Bevacizumab 5.0mg/kg i.v. together with leucovorin 400 mg/m2 i.v. all on day 1. Followed by continuous infusion of 5-fluorouracil 3200 mg/m2 in 46 hours. 5-FU + bevacizumab is repeated every two weeks. When S1 is used a replacement for fluoropyrimidine therapy it is administered in a dose of 30mg/m2 twice daily on days 1-14. S1 is repeated every three weeks. | Drug | Systemic maintenance therapy, Systemic maintenance therapy in combination with stereotactic body radiation therapy (SBRT) |
Primary outcome
Progression-free survival
Time frame: Through study completion, an average of 24 months
Defined as time from randomization to progression of disease or death, whichever occurs first. Progression of disease is based on tumor response as observed on radiographic imaging according to the RECIST 1.1 criteria.
11 secondary outcomes
Accrual rate as assessed by the number of patients included in the study compared to the expected accrual rate.
Time frame: Through study completion, an average of 24 months
Treatment success rate
Time frame: Through study completion, an average of 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, an average of 24 months
Overall survival
Time frame: Up to 72 months
Comparing changes on health-related quality of life based on summary score of Quality of Life Questionnaire-Core30 (QLQ-C30) from baseline and 3-monthly timepoints.
Time frame: Through study completion, an average of 24 months
Comparing changes on health-related quality of life based on summary score of Quality of Life Questionnaire-Core29 (QLQ-C29) from baseline and 3-monthly timepoints.
Time frame: Through study completion, an average of 24 months
Comparing changes from health-related quality of life based on summary score of Multidimensional Fatigue Inventory (MFI-20) from baseline and 3-monthly timepoints.
Time frame: Through study completion, an average of 24 months
Pattern of reccurence according to RECIST 1.1: New metastatic lesions, progression of existing lesions or a combination.
Time frame: Through study completion, an average of 24 months
Time to treatment failure
Time frame: Through study completion, an average of 24 months
Tumor response
Time frame: Through study completion, an average of 24 months
Depth of response
Time frame: Through study completion, an average of 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guus Bol, Dr. principal investigator
UMC Utrecht
Martijn Intven, Dr. principal investigator
UMC Utrecht
Miriam Koopman, Prof. Dr. principal investigator
UMC Utrecht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiation therapy (SBRT) and Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.) in people with Metastatic Colorectal Cancer and Oligometastatic Disease, run by UMC Utrecht at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Through study completion, an average of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.