Metastatic Colorectal CancerPhase 2STARLIGHTNCT06563986
FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
A Phase 2 study testing Systemic treatment (FTD-TPI and bevacizumab) and Radioembolization with 166-Ho microspheres in people with Metastatic Colorectal Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Extrahepatic disease progression limits clinical efficacy of individualized radioembolization for patients with refractory metastatic colorectal cancer (mCRC). In the same patient population, trifluridine/tipiracil (FTD-TPI) and bevacizumab lead to disease control and overall survival benefit and may be a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Systemic treatment (FTD-TPI and bevacizumab) and Radioembolization with 166-Ho microspheres
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jun 2024to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Unresectable liver dominant mCRC
- Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the treatment of metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
- Patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be eligible to enter the study.
- Patients who refuse oxaliplatin or irinotecan will also be eligible to enter the study.
- Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy count the adjuvant therapy as treatment of metastatic colorectal cancer.
- Written informed consent
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- Age >=18 years
- Estimated hepatic tumor replacement ≥ 10% and ≤ 50% of total liver volume Eastern Cooperative Oncology Group performance status 0-1
- Adequate organ function as measured by: WBC ≥ 3.0 x 109/L, platelets ≥ 100 x 109/L, absolute neutrophil count > 1.5 x 109/L, Hemoglobin (Hb) > 5 mmol/L (>8.1 g/dL), eGFR ≥ 35 ml/min, Serum transaminases (AST \& ALT) ≤ 5 x upper limit of normal (ULN), Total bilirubin ≤ ULN, Albumin > 3 g/dL
- At least one measurable liver lesion according to the PERCIST 1.0
Who cannot join
- Significant extrahepatic disease, defined as symptomatic extrahepatic disease, more than 10 pulmonary nodules (maximum diameter of each lung metastasis <20mm), and/or peritoneal carcinomatosis.
- Eligible for ablative local treatment of liver metastases (e.g. surgical resection, ablation)
- Lung shunt >20 Gy, as calculated using scout dose SPECT/CT
- Absorbed tumor dose <90 Gy when dosing at a maximum average absorbed normal liver dose
- Other malignancy confounding prognosis
- Receipt of chemotherapy within 28 days prior to study treatment
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- Previous or current treatment with radioembolization
- Major surgery within 28 days or incompletely healed surgical incision before starting study therapy
- Any serious comorbidity preventing the safe administration of anti-VEGF antibody treatment. This includes uncontrolled hypertension or treatment with ≥3 antihypertensive drugs, arterial (cerebro)vascular event within the past 6 months, history of severe bleeding, history of GI perforation, or presence of fistulae
- Any serious and/or chronic liver disease preventing the safe administration of radio- embolization
- Uncorrectable extrahepatic deposition of scout dose activity; activity in the falciform ligament, portal lymph nodes and gallbladder is accepted
- Pregnancy or breastfeeding
- Body weight over 150 kg (because of maximum table load)
- Known severe allergy for intravenous contrast fluids
- Participation to another investigational study which may compromise any endpoint of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dania Al-Toma, drs. contact
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, 3584CX
Guus Bol, dr.
Guus Bol, dr.
About this study
Official title: Single-arm, Phase II Trial of Trifluridine/Tipiracil (FTD-TPI), Bevacizumab, and Individualized Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
Extrahepatic disease progression limits clinical efficacy of individualized radioembolization for patients with refractory metastatic colorectal cancer (mCRC). In the same patient population, trifluridine/tipiracil (FTD-TPI) and bevacizumab lead to disease control and overall survival benefit and may be a radiosensitizer.
The purpose of this study is to determine safety, tolerability, and activity of individualized radioembolization with 166Holmium (166Ho)-microspheres combined with FTD-TPI and bevacizumab.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Systemic treatment (FTD-TPI and bevacizumab), Radioembolization with 166-Ho microspheres
- Keywords
- Radioembolization, Trifluridine/Tipiracil, Refractory Metastatic Colorectal Cancer, Radioembolization With 166Ho-microspheres
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic treatment (FTD-TPI and bevacizumab)Drug
Systemic treatment (FTD-TPI and bevacizumab) administration is according to standard clinical practice. Each treatment cycle will be 28 days in duration.
One treatment cycle consists of the following:
- Days 1-5: oral intake of FTD-TPI and bevacizumab IV infusion on day 1
- Days 8-12: oral intake of FTD-TPI
- Day 15: bevacizumab IV infusion
Bevacizumab 5.0mg/kg i.v. is repeated every 2 weeks. If toxicity occurs, dose modifications and dose delays should be administered and applied according to standard practice.
Radioembolization with 166-Ho microspheresDevice
Individualized 166Ho radioembolization will be performed via a catheter during angiography. Before the treatment, a scout procedure will be performed to determine individualized 166Ho dose of the treatment. Dosimetry-based treatment planning will be individualized using Q- Suite software.
In case of bilateral disease, patients will be treated in two procedures to each hemi-liver, separated by 1 month. Before the first procedure, a scout procedure will be performed in which the individualized 166Ho dose of the first and second procedure will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Systemic treatment (FTD-TPI + bevacizumab) and radioembolization | Experimental | * Individualized dose 166Ho radioembolization, combined with systemic treatment:
* 35 mg/m2 FTD-TPI on day 1-5 and 8-12 every 4 weeks
* 5 mg/kg bevacizumab iv. on day 1 and 15 every 4 weeks Receives: Drug: Systemic treatment (FTD-TPI and bevacizumab); Device: Radioembolization with 166-Ho microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic objective response rate (hORR) (PERCIST 1.0)
Hepatic objective response rate (hORR) will be assessed by Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) 1.0.
Measured: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Secondary outcomes (11)
Hepatic objective response rate (hORR) (RECIST 1.1)
Hepatic objective response rate (hORR) will be assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Measured: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Overall and extra-hepatic ORR (RECIST 1.1)
Overall and extra-hepatic ORR will be assessed by RECIST 1.1.
Measured: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Overall and extra-hepatic ORR (PERCIST 1.0)
Overall and extra-hepatic ORR will be assessed by PERCIST 1.0.
Measured: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Serious adverse events (SAE's)
The occurrence of any (suspected unexpected) serious adverse event (SAE) that is possibly, probably or definitely related to the combined treatment.
Measured: Evaluated every 8 weeks after start treatment during the first half year. The collection period will start from the first day of the first treatment cycle until 180 days thereafter.
Grade ≥3 adverse events (CTCAE 5.0)
The rate of grade ≥3 adverse events (CTCAE 5.0).
Measured: Evaluated every 8 weeks after start treatment during the first half year. The collection period will start from the first day of the first treatment cycle until 180 days thereafter.
Occurrence of radioembolization-induced liver disease (REILD)
Radioembolization-induced liver disease (REILD) is defined as a total bilirubin increase to grade ≥3 or higher according to the CTCAE v5.0, in combination with ascites and low albumin, developing at least 2 weeks after radioembolization and up to 4 months after radioembolization, in the absence of tumor progression or biliary obstruction.
Measured: Evaluated every 8 weeks after start treatment during the first half year.
Radioembolization related vascular events
Number of participants with a vascular event (dissection, pseudo-aneurism, thrombus etc.) that is possibly, probably or definitely related to the radioembolization.
Measured: Evaluated every 8 weeks after start treatment during the first half year.
Dose reductions, dose delays of FTD-TPI
The frequency of dose reductions and dose delays of FTD-TPI during the first 2 cycles.
Measured: Evaluated during the first two cycles (each cycle is 28 days).
Radioembolization completion rate
Defined as the successful treatment of both hemi-livers (in case of bilateral disease) according to the individualized treatment plan designed at the scout dose.
Measured: Evaluated immediately after the radioembolization treatment.
Progression free survival (PFS)
PFS is defined as time from the first day of the first treatment cycle to progression of disease or death, whichever occurs first. Progression of disease is based on tumor response as observed on radiographic imaging according to RECIST 1.1.
Measured: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Overall survival (OS)
OS is defined as the time from the first day of the first treatment cycle to the date of death. Patients still alive at the analysis cut-off date are censored at the last date known to be alive. OS will be collected for all patients from the Personal Records Database (BRP), yearly during the duration of the study.
Measured: Evaluated once per year until the end of the study (the end of study is defined as six months after the first day of the first treatment cycle (each cycle is 28 days) of the 36th evaluable participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start18 Jun 2024
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guus Bol, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563986
- Sponsor's protocol ID
- NL85987.041.24
- Acronym
- STARLIGHT
- Status last verified
- Aug 2024
- First submitted
- 7 Jun 2024
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Phase II Trial of Trifluridine/Tipiracil (FTD-TPI), Bevacizumab, and Individualized Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06563986
- Acronym / sponsor ID
- STARLIGHT / NL85987.041.24
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Radioembolization, Trifluridine/Tipiracil, Refractory Metastatic Colorectal Cancer, Radioembolization With 166Ho-microspheres
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Aug 2024 (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.
Extrahepatic disease progression limits clinical efficacy of individualized radioembolization for patients with refractory metastatic colorectal cancer (mCRC). In the same patient population, trifluridine/tipiracil (FTD-TPI) and bevacizumab lead to disease control and overall survival benefit and may be a radiosensitizer.
The purpose of this study is to determine safety, tolerability, and activity of individualized radioembolization with 166Holmium (166Ho)-microspheres combined with FTD-TPI and bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Systemic treatment (FTD-TPI + bevacizumab) and radioembolization | Experimental | Drug: Systemic treatment (FTD-TPI and bevacizumab), Device: Radioembolization with 166-Ho microspheres* Individualized dose 166Ho radioembolization, combined with systemic treatment: * 35 mg/m2 FTD-TPI on day 1-5 and 8-12 every 4 weeks * 5 mg/kg bevacizumab iv. on day 1 and 15 every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Unresectable liver dominant mCRC
- Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the treatment of metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
- Written informed consent
- Age >=18 years
- Estimated hepatic tumor replacement ≥ 10% and ≤ 50% of total liver volume Eastern Cooperative Oncology Group performance status 0-1
Key exclusion criteria (15 listed)
- Significant extrahepatic disease, defined as symptomatic extrahepatic disease, more than 10 pulmonary nodules (maximum diameter of each lung metastasis <20mm), and/or peritoneal carcinomatosis.
- Eligible for ablative local treatment of liver metastases (e.g. surgical resection, ablation)
- Lung shunt >20 Gy, as calculated using scout dose SPECT/CT
- Absorbed tumor dose <90 Gy when dosing at a maximum average absorbed normal liver dose
- Other malignancy confounding prognosis
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 |
|---|---|---|
| Systemic treatment (FTD-TPI and bevacizumab)Systemic treatment (FTD-TPI and bevacizumab) administration is according to standard clinical practice. Each treatment cycle will be 28 days in duration. One treatment cycle consists of the following: * Days 1-5: oral intake of FTD-TPI and bevacizumab IV infusion on day 1 * Days 8-12: oral intake of FTD-TPI * Day 15: bevacizumab IV infusion Bevacizumab 5.0mg/kg i.v. is repeated every 2 weeks. If toxicity occurs, dose modifications and dose delays should be administered and applied according to standard practice. | Drug | Intervention: Systemic treatment (FTD-TPI + bevacizumab) and radioembolization |
| Radioembolization with 166-Ho microspheresIndividualized 166Ho radioembolization will be performed via a catheter during angiography. Before the treatment, a scout procedure will be performed to determine individualized 166Ho dose of the treatment. Dosimetry-based treatment planning will be individualized using Q- Suite software. In case of bilateral disease, patients will be treated in two procedures to each hemi-liver, separated by 1 month. Before the first procedure, a scout procedure will be performed in which the individualized 166Ho dose of the first and second procedure will be calculated. | Device | Intervention: Systemic treatment (FTD-TPI + bevacizumab) and radioembolization |
Primary outcome
Hepatic objective response rate (hORR) (PERCIST 1.0)
Time frame: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Hepatic objective response rate (hORR) will be assessed by Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) 1.0.
11 secondary outcomes
Hepatic objective response rate (hORR) (RECIST 1.1)
Time frame: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Overall and extra-hepatic ORR (RECIST 1.1)
Time frame: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Overall and extra-hepatic ORR (PERCIST 1.0)
Time frame: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Serious adverse events (SAE's)
Time frame: Evaluated every 8 weeks after start treatment during the first half year. The collection period will start from the first day of the first treatment cycle until 180 days thereafter.
Grade ≥3 adverse events (CTCAE 5.0)
Time frame: Evaluated every 8 weeks after start treatment during the first half year. The collection period will start from the first day of the first treatment cycle until 180 days thereafter.
Occurrence of radioembolization-induced liver disease (REILD)
Time frame: Evaluated every 8 weeks after start treatment during the first half year.
Radioembolization related vascular events
Time frame: Evaluated every 8 weeks after start treatment during the first half year.
Dose reductions, dose delays of FTD-TPI
Time frame: Evaluated during the first two cycles (each cycle is 28 days).
Radioembolization completion rate
Time frame: Evaluated immediately after the radioembolization treatment.
Progression free survival (PFS)
Time frame: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.
Overall survival (OS)
Time frame: Evaluated once per year until the end of the study (the end of study is defined as six months after the first day of the first treatment cycle (each cycle is 28 days) of the 36th evaluable participant).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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CRC
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.
Dania Al-Toma, drs. contact
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 Systemic treatment (FTD-TPI and bevacizumab) and Radioembolization with 166-Ho microspheres in people with Metastatic Colorectal Cancer, run by UMC Utrecht 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 21 Aug 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guus Bol, dr. (+31 88 75 652 43, G.M.Bol-2@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic objective response rate (hORR) (PERCIST 1.0) (time frame: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first.). 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 21 Aug 2024.