Colonic NeoplasmsNCT03175146
A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
A study testing Stereotactic Body Radiation Therapy in people with Colonic Neoplasms and Neoplasm Metastasis, run by AHS Cancer Control Alberta.
Trial summary
The proposed study will evaluate if "curative intent" SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Neoplasms, Neoplasm Metastasis
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Jan 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed Colo-rectal Cancer
- 1-3 Liver metastasis measurable on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- Surgically resected primary disease
- Technically/medically inoperable or patient declined surgery
- Progression or Stability after at least 1 Line of chemotherapy
- Adequate marrow function: Hb > 80g/L, Platelets > 100 x 109/L, White blood cell > 2 x 109/L
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Age > 18 years
- Patient must sign study specific informed consent prior to study entry
Who cannot join
- Prior liver radiation, or radiation in close proximity to planned treatment sites
- Prior invasive malignancy
- Severe, active co-morbidity
- Active hepatitis or Child Pugh Score B (9) or worse
- Pregnant or nursing women
- Extra hepatic disease: Any Bone/Any Brain, 2 or more Lung metastasis
Show all 9Show fewer
- Life expectancy < 6 mo from any cause
- Concurrent chemotherapy
- Response to prior chemotherapy with minimal measurable disease in liver
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression
The proposed study will evaluate if "curative intent" SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy
Read the detailed description
SBRT for Oligo-metastatic Colorectal cancer
- Conditions
- Colonic Neoplasms, Neoplasm Metastasis
- Being tested
- Stereotactic Body Radiation Therapy
- Medical subject headings
- Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
5 treatments given over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Stereotactic Body Radiation Therapy Receives: Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate within the treated liver lesion
RECIST Response
Measured: 6 months
Secondary outcomes (5)
Progression-free survival
Any progression of the disease
Measured: Up to 5 years
Toxicity
Grade 3 CTCAE events
Measured: From date of randomization up to 5 years
Quality of Life
Fact - H quality of life instrument
Measured: From date of Randomization to Death or Progression or 5 years whichever comes first.
Median survival
Median survival
Measured: From date of randomization upto 5 years
Overall survival
Survival
Measured: From date of randomization upto 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startSep 2017 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richie Sinha, MD, Principal investigator, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175146
- Sponsor's protocol ID
- CRC L-SBRT 15-01
- Status last verified
- May 2017
- First submitted
- 6 Jan 2016
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression
- ClinicalTrials.gov ID
- NCT03175146
- Acronym / sponsor ID
- CRC L-SBRT 15-01
- Conditions
- Colonic Neoplasms, Neoplasm Metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 5 Jun 2017 (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.
The proposed study will evaluate if "curative intent" SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy
Detailed description
SBRT for Oligo-metastatic Colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Radiation: Stereotactic Body Radiation TherapyStereotactic Body Radiation Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically confirmed Colo-rectal Cancer
- 1-3 Liver metastasis measurable on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- Surgically resected primary disease
- Technically/medically inoperable or patient declined surgery
- Progression or Stability after at least 1 Line of chemotherapy
Key exclusion criteria (9 listed)
- Prior liver radiation, or radiation in close proximity to planned treatment sites
- Prior invasive malignancy
- Severe, active co-morbidity
- Active hepatitis or Child Pugh Score B (9) or worse
- Pregnant or nursing women
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 TherapyAlso: SBRT5 treatments given over 2 weeks | Radiation | Experimental |
Primary outcome
Response rate within the treated liver lesion
Time frame: 6 months
RECIST Response
5 secondary outcomes
Progression-free survival
Time frame: Up to 5 years
Toxicity
Time frame: From date of randomization up to 5 years
Quality of Life
Time frame: From date of Randomization to Death or Progression or 5 years whichever comes first.
Median survival
Time frame: From date of randomization upto 5 years
Overall survival
Time frame: From date of randomization upto 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: Yes
Related trials for Colonic Neoplasms
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
Recruiting
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Colorectal Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
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.
Richie Sinha, MD principal investigator
Tom Baker Cancer Centre
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy in people with Colonic Neoplasms and Neoplasm Metastasis, run by AHS Cancer Control Alberta.
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 9 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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richie Sinha, MD (403-476-2601, richie.sinha@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate within the treated liver lesion (time frame: 6 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 7 Jun 2017.