Colorectal Cancer MetastaticPhase 2NCT05062720
Local Consolidative Therapy in Colorectal Cancer
A Phase 2 study testing Local consolidative therapy in people with Colorectal Cancer Metastatic, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This is a Phase II randomized multisite trial to study the effect of a combination of local consolidative therapy with systemic therapy in subjects with oligometastatic colorectal cancer who have progressed on the first line of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Local consolidative therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 31 Oct 2025
- 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
- Subjects must have histologically or cytologically confirmed metastatic colorectal cancer with 1-3 active metastatic lesions irrespective of location. Previously locally treated (e.g. radiation or interventional radiology-based ablated) metastases that have had a 6-month progression free interval per imaging exams, do not count toward the 1-3 active metastases. Adjacent lymph nodes in the same region constitute one active lesion.
- Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 12.0.
- All sites of metastatic disease must be amenable to either surgical resection or stereotactic body radiotherapy (SBRT).
- The primary lesion may be either intact or previously resected, but if intact must be resected as part of LCT (primary does not count as one of 1-3 sites of metastatic disease).
- Subjects must have received at least one prior line of systemic therapy with a fluoropyrimidine-based regimen for metastatic disease and be candidates for further systemic chemotherapy. Front-line therapy could have been discontinued for disease progression, unacceptable toxicity, or drug holiday, provided that the therapy was discontinued less than six months from study enrollment.
- Age > 18 years.
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- ECOG performance status 0 or 1
- Subjects must have normal organ and marrow function as defined below
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- Total bilirubin < 2 mg/dL
- AST/ALT (SGOT/SGPT) < 5X ULN
- Creatinine < 1.5X ULN OR
- Creatinine clearance < 50 ml/min/1.73 m2 for subjects with creatinine levels above institutional normal
- Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document.
Who cannot join
- Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous oxaliplatin exposure, alopecia and fatigue.
- >Grade 2 sensory neuropathy
- Subjects must not be receiving any other investigational agents.
- Subjects must not have known central nervous system (CNS) metastases and/or carcinomatous meningitis, either untreated or treated.
- Subjects must not be unfit to receive combination therapy (>/=2 drugs that could include one biologic agent) as determined by the treating physician.
- Subjects must be able to undergo surgical resection and/or SBRT.
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- Subjects must not have 4 or more active metastatic sites.
- Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any condition or significant co-morbidity that prevents safe surgery or delivery of SBRT
- Subjects must not be pregnant or breast feeding. Refer to section 4.4 for further detail.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: RT-167: Local Consolidative Therapy in Colorectal Cancer
This is a Phase II randomized multisite trial to study the effect of a combination of local consolidative therapy with systemic therapy in subjects with oligometastatic colorectal cancer who have progressed on the first line of therapy.
Read the detailed description
This is a Phase II randomized multisite trial to study the effect of a combination of local consolidative therapy with systemic therapy in subjects with oligometastatic colorectal cancer who have progressed on the first line of therapy. The primary objective of this study is progression free survival which is defined as time from randomization until disease progression is documented. Response will be evaluated by scans every 3 months (+/- 7 days). Subjects will continue systemic therapy for 6 months and then at the investigator's discretion, disease progression or unacceptable toxicity. Subjects who are not evaluable for the primary endpoint will be replaced. A total of 105 subjects will be randomized in 2:1 ratio into two cohorts that will receive a combination of LCT along with the systemic therapy or systemic therapy alone.
Arm A: LCT + systemic therapy; 70 subjects will be accrued Arm B: Systemic therapy alone; 35 subjects will be accrued
Systemic therapy will be second line chemotherapy as per NCCN guidelines with the choice of drugs at the treating physician's discretion. Crossover to LCT will be allowed at progression for subjects randomized to Arm B.
The study will be opened at a total of 5 sites with a duration of 26 months of accrual and 10 additional months of follow-up, with a total of 36 months. The study will be conducted in 2 phases with an interim analysis conducted when 29 PFS events have been observed to assess futility/ feasibility of the study.
Subjects will have the option of undergoing tumor biopsy and blood sampling before beginning treatment. A correlative study is proposed using the genomic risk group stratification proposed by Pitroda et al.[9] Collected blood will be analyzed at the conclusion of the trial, with the expectation of comparing levels of circulating tumor DNA between baseline and 3-month time-points between subjects in Arms A and B. As this technology is rapidly evolving, we are not specifying the technology that will be used and will use the most effective assay at the time of trial completion.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Local consolidative therapy
- Keywords
- oligometastatic, colorectal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local consolidative therapyRadiation
Local Consolidative Therapy (LCT) will be defined as surgical resection or stereotactic body radiotherapy (SBRT) or a combination of both strategies
| Study group | Role | What they receive |
|---|---|---|
| Local consolidative therapy (LCT) + systemic therapy | Experimental | Local Consolidative Therapy (LCT) will be defined as surgical resection or stereotactic body radiotherapy (SBRT) or a combination of both strategies Receives: Radiation: Local consolidative therapy |
| Systemic therapy alone | Active comparator | Appropriate second-line systemic therapy, as defined in the NCCN guidelines will be used during study treatment (https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf). The choice of specific regimen will be left to the discretion of the treating oncologist but cannot include other experimental or investigational treatment. Sample appropriate systemic therapies include FOLFOX or FOLFIRI with a biologic agent such as an anti-angiogenic antibody or anti-EGFR antibody. Receives: Radiation: Local consolidative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
To assess the impact of local consolidative therapy (LCT) (surgical resection and/or radiotherapy) on the PFS of subjects with oligometastatic colorectal cancer undergoing second-line systemic therapy. PFS- defined as the duration of time from randomization to date of disease progression or death, whichever occurs first. Individuals who are alive and progression free at last follow-up will be considered censored at the time of last tumor assessment.
Measured: 6 months
Secondary outcomes (2)
Overall suvival (OS)
To assess the impact of local consolidative therapy (LCT) (surgical resection and/or radiotherapy) on the overall survival (OS) of subjects with oligometastatic colorectal cancer undergoing second-line systemic therapy. • OS - defined as the duration of time from randomization to date of death. Individuals who are alive at last follow-up will be considered censored at the time of last contact.
Measured: 6 months
Patient reported outcomes (PROs)
To assess patient reported outcomes (PROs) as measured by the EQ-5D-5L instrument. • PRO - defined as the score on the EQ-5D-5L questionnaire, this will be measured at baseline, and then 2 other times after treatment has begun
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start29 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Oct 2025 (estimated)
Why it stopped: Study is being closed due to lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Crossover
- Model description
- A total of 105 subjects will be randomized in 2:1 ratio into two cohorts that will receive a combination of LCT along with the systemic therapy or systemic therapy alone.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062720
- Sponsor's protocol ID
- 20-1010
- Other IDs
- RT-167
- Status last verified
- Dec 2022
- First submitted
- 21 Sep 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RT-167: Local Consolidative Therapy in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05062720
- Acronym / sponsor ID
- 20-1010
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- oligometastatic, colorectal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is being closed due to lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 30 Sep 2021 (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.
This is a Phase II randomized multisite trial to study the effect of a combination of local consolidative therapy with systemic therapy in subjects with oligometastatic colorectal cancer who have progressed on the first line of therapy.
Detailed description
This is a Phase II randomized multisite trial to study the effect of a combination of local consolidative therapy with systemic therapy in subjects with oligometastatic colorectal cancer who have progressed on the first line of therapy. The primary objective of this study is progression free survival which is defined as time from randomization until disease progression is documented. Response will be evaluated by scans every 3 months (+/- 7 days). Subjects will continue systemic therapy for 6 months and then at the investigator's discretion, disease progression or unacceptable toxicity. Subjects who are not evaluable for the primary endpoint will be replaced. A total of 105 subjects will be randomized in 2:1 ratio into two cohorts that will receive a combination of LCT along with the systemic therapy or systemic therapy alone.
Arm A: LCT + systemic therapy; 70 subjects will be accrued Arm B: Systemic therapy alone; 35 subjects will be accrued
Systemic therapy will be second line chemotherapy as per NCCN guidelines with the choice of drugs at the treating physician's discretion. Crossover to LCT will be allowed at progression for subjects randomized to Arm B.
The study will be opened at a total of 5 sites with a duration of 26 months of accrual and 10 additional months of follow-up, with a total of 36 months. The study will be conducted in 2 phases with an interim analysis conducted when 29 PFS events have been observed to assess futility/ feasibility of the study.
Subjects will have the option of undergoing tumor biopsy and blood sampling before beginning treatment. A correlative study is proposed using the genomic risk group stratification proposed by Pitroda et al.[9] Collected blood will be analyzed at the conclusion of the trial, with the expectation of comparing levels of circulating tumor DNA between baseline and 3-month time-points between subjects in Arms A and B. As this technology is rapidly evolving, we are not specifying the technology that will be used and will use the most effective assay at the time of trial completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 105 subjects will be randomized in 2:1 ratio into two cohorts that will receive a combination of LCT along with the systemic therapy or systemic therapy alone.
| Arm | Type | Receives |
|---|---|---|
| Local consolidative therapy (LCT) + systemic therapy | Experimental | Radiation: Local consolidative therapyLocal Consolidative Therapy (LCT) will be defined as surgical resection or stereotactic body radiotherapy (SBRT) or a combination of both strategies |
| Systemic therapy alone | Active comparator | Radiation: Local consolidative therapyAppropriate second-line systemic therapy, as defined in the NCCN guidelines will be used during study treatment (https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf). The choice of specific regimen will be left to the discretion of the treating oncologist but cannot include other experimental or investigational treatment. Sample appropriate systemic therapies include FOLFOX or FOLFIRI with a biologic agent such as an anti-angiogenic antibody or anti-EGFR antibody. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must have histologically or cytologically confirmed metastatic colorectal cancer with 1-3 active metastatic lesions irrespective of location. Previously locally treated (e.g. radiation or interventional radiology-based ablated) metastases that have had a 6-month progression free interval per imaging exams, do not count toward the 1-3 active metastases. Adjacent lymph nodes in the same region constitute one active lesion.
- Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 12.0.
- All sites of metastatic disease must be amenable to either surgical resection or stereotactic body radiotherapy (SBRT).
- The primary lesion may be either intact or previously resected, but if intact must be resected as part of LCT (primary does not count as one of 1-3 sites of metastatic disease).
- Subjects must have received at least one prior line of systemic therapy with a fluoropyrimidine-based regimen for metastatic disease and be candidates for further systemic chemotherapy. Front-line therapy could have been discontinued for disease progression, unacceptable toxicity, or drug holiday, provided that the therapy was discontinued less than six months from study enrollment.
Key exclusion criteria (10 listed)
- Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous oxaliplatin exposure, alopecia and fatigue.
- >Grade 2 sensory neuropathy
- Subjects must not be receiving any other investigational agents.
- Subjects must not have known central nervous system (CNS) metastases and/or carcinomatous meningitis, either untreated or treated.
- Subjects must not be unfit to receive combination therapy (>/=2 drugs that could include one biologic agent) as determined by the treating physician.
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 |
|---|---|---|
| Local consolidative therapyLocal Consolidative Therapy (LCT) will be defined as surgical resection or stereotactic body radiotherapy (SBRT) or a combination of both strategies | Radiation | Local consolidative therapy (LCT) + systemic therapy, Systemic therapy alone |
Primary outcome
Progression free survival
Time frame: 6 months
To assess the impact of local consolidative therapy (LCT) (surgical resection and/or radiotherapy) on the PFS of subjects with oligometastatic colorectal cancer undergoing second-line systemic therapy. PFS- defined as the duration of time from randomization to date of disease progression or death, whichever occurs first. Individuals who are alive and progression free at last follow-up will be considered censored at the time of last tumor assessment.
2 secondary outcomes
Overall suvival (OS)
Time frame: 6 months
Patient reported outcomes (PROs)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Joshua Meyer, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Local consolidative therapy in people with Colorectal Cancer Metastatic, run by Fox Chase Cancer Center at 1 site in United States.
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 15 inclusion and 10 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: withdrawn, as of the sponsor's last update on 9 Dec 2022. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: 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 9 Dec 2022.