OligometastasesSABR-SCANNCT02414334
SABR-SCAN Trial for Pulmonary Oligometastases
A study testing Stereotactic Ablative Radiotherapy (SABR) in people with Oligometastases, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides surgical resection for limited lung metastases (oligometastases) from colorectal cancer. High efficacy in terms of local control of metastatic lesions treated has been shown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastases
- What is being tested?
- Stereotactic Ablative Radiotherapy (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Jun 2019
- Phase
- Interventional
- 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
- Age ≥ 18 years
- WHO-Performance status (WHO-PS) 0 - 1
- Patients with 1 to 3 lung metastases between 8 mm and 3 cm each, from colorectal cancer. Resection has been considered at a multidisciplinary conference but was not recommended or has been refused by the patient.
- Possibility to define target lesions that fulfil the following criteria:
- No lesion larger than 3 cm;
- Not more than 3 metastases ≥ 8 mm in total (lesions smaller than 8 mm in diameter are NOT counted and will NOT be irradiated);
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- No prior radiotherapy (SABR or other) within about 2 cm from target lesions (i.e., the distance between prior planning-target-volume (PTV) to actual intended PTV is more than 2 cm AND dose distribution of former radiation permits SABR).
- Primary tumour has been completely removed surgically.
- Metastases outside target organs (e.g. liver metastases or other) are radically treated locally (resection, radiofrequency ablation (RFA), microwave ablation (MWA), stereotactic radiotherapy, or other). Earlier resected or ablated (SABR, RFA, MWA) metastases to lung, liver, or other organ form no exclusion criterion. Brain metastases should be completely resected or treated with stereotactic radiosurgery. Bone metastases should be resected or treated with high dose radiotherapy (equivalent of > 40 Gy) and be asymptomatic.
- Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
- Proficiency in the Dutch language so that quality-of-life questionnaires can be completed in Dutch and absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Before patient randomisation, informed consent must be given according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) of the European Union (EU) in accordance with good clinical practice (GCP), and national/local regulations.
Who cannot join
- Any clinical symptoms possibly or certainly caused by index lungmetastases
- Physical inability to undergo stereotactic radiotherapy (e.g., serious shoulder stiffness)
- Any uncontrolled malignancy other than index colorectal cancer
- Other malignancy within recent two years, even if completely under control (under control = no evidence of disease)
- Failure to comply with any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Versus Delayed Stereotactic Ablative Radiotherapy (SABR) for Patients With Pulmonary Oligometastases From Colorectal Cancer: SABR SCAN Trial A Randomised Clinical Trial
Rationale:
SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides surgical resection for limited lung metastases (oligometastases) from colorectal cancer. High efficacy in terms of local control of metastatic lesions treated has been shown. Nevertheless, the precise effect of SABR upon progression-free- and overall survival in these patients is unknown. To further evaluate and develop local treatment options in metastatic disease, more information is necessary regarding the impact upon - and the pattern of - disease progression of local treatment options such as SABR.
Read more
Objective:
To determine the effect upon progression free survival and upon tumorload relative to baseline, both at one year after randomisation of immediate SABR versus delayed SABR (a scan-and-personalise policy). Secondarily, patterns of progression, patient-reported symptoms and quality of life will be monitored.
- Conditions
- Oligometastases
- Being tested
- Stereotactic Ablative Radiotherapy (SABR)
- Keywords
- Oligometastases, Stereotactic ablative radiotherapy (SABR), Metastatic tumours
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Radiotherapy (SABR)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Immediate SABR | Active comparator | Immediate stereotactic ablative radiotherapy (standard arm) Receives: Radiation: Stereotactic Ablative Radiotherapy (SABR) |
| Delayed SABR | Experimental | Delayed stereotactic ablative radiotherapy (delayed= treatment six months after randomisation or at disease progression) (experimental arm) Receives: Radiation: Stereotactic Ablative Radiotherapy (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: 12 months after randomisation
Secondary outcomes (5)
Relative change of tumourload expressed as volume of all tumour at one year divided by volume of all tumour at time of randomisation;
Measured: 12 months after randomisation
Time to failure of local strategy (TFLS): failure = death or progressive disease NOT amenable to local treatment
Measured: when it occurs
Progression of target lesions as measured by CT
Measured: 12 months after randomisation
Health-related quality of life profile
Euro-Qol 5 dimensions (EuroQoL-5D); Hospital Anxiety and Depression Scale (HADS); European Organization for Research and Treatment of Cancer quality of life questionnaire - lung cancer module (EORTC-QLQ-LC13)
Measured: Baseline; 3 months after randomisation and at 6, 9, 12, 15, 18, 21 and 24 months
Progression of lesions other than target lesions as measured by CT
Measured: 12 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligometastasesStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414334
- Sponsor's protocol ID
- RT2015-02
- Acronym
- SABR-SCAN
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2015
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Stereotactic Ablative Radiotherapy (SABR) for Patients With Pulmonary Oligometastases From Colorectal Cancer: SABR SCAN Trial A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02414334
- Acronym / sponsor ID
- SABR-SCAN / RT2015-02
- Conditions
- Oligometastases
- Keywords
- Oligometastases, Stereotactic ablative radiotherapy (SABR), Metastatic tumours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 10 Apr 2015 (estimated)
- 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.
Rationale:
SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides surgical resection for limited lung metastases (oligometastases) from colorectal cancer. High efficacy in terms of local control of metastatic lesions treated has been shown. Nevertheless, the precise effect of SABR upon progression-free- and overall survival in these patients is unknown. To further evaluate and develop local treatment options in metastatic disease, more information is necessary regarding the impact upon - and the pattern of - disease progression of local treatment options such as SABR.
Objective:
To determine the effect upon progression free survival and upon tumorload relative to baseline, both at one year after randomisation of immediate SABR versus delayed SABR (a scan-and-personalise policy). Secondarily, patterns of progression, patient-reported symptoms and quality of life will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate SABR | Active comparator | Radiation: Stereotactic Ablative Radiotherapy (SABR)Immediate stereotactic ablative radiotherapy (standard arm) |
| Delayed SABR | Experimental | Radiation: Stereotactic Ablative Radiotherapy (SABR)Delayed stereotactic ablative radiotherapy (delayed= treatment six months after randomisation or at disease progression) (experimental arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- WHO-Performance status (WHO-PS) 0 - 1
- Patients with 1 to 3 lung metastases between 8 mm and 3 cm each, from colorectal cancer. Resection has been considered at a multidisciplinary conference but was not recommended or has been refused by the patient.
- Possibility to define target lesions that fulfil the following criteria:
- No prior radiotherapy (SABR or other) within about 2 cm from target lesions (i.e., the distance between prior planning-target-volume (PTV) to actual intended PTV is more than 2 cm AND dose distribution of former radiation permits SABR).
Key exclusion criteria (5 listed)
- Any clinical symptoms possibly or certainly caused by index lungmetastases
- Physical inability to undergo stereotactic radiotherapy (e.g., serious shoulder stiffness)
- Any uncontrolled malignancy other than index colorectal cancer
- Other malignancy within recent two years, even if completely under control (under control = no evidence of disease)
- Failure to comply with any of the inclusion criteria
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 Ablative Radiotherapy (SABR) | Radiation | Delayed SABR, Immediate SABR |
Primary outcome
Progression free survival (PFS)
Time frame: 12 months after randomisation
5 secondary outcomes
Relative change of tumourload expressed as volume of all tumour at one year divided by volume of all tumour at time of randomisation;
Time frame: 12 months after randomisation
Time to failure of local strategy (TFLS): failure = death or progressive disease NOT amenable to local treatment
Time frame: when it occurs
Progression of target lesions as measured by CT
Time frame: 12 months after randomisation
Health-related quality of life profile
Time frame: Baseline; 3 months after randomisation and at 6, 9, 12, 15, 18, 21 and 24 months
Progression of lesions other than target lesions as measured by CT
Time frame: 12 months after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Ablative Radiotherapy (SABR) in people with Oligometastases, run by University Medical Center Groningen at 1 site 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 12 inclusion and 5 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (PFS) (time frame: 12 months after randomisation). 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 1 Mar 2024.