Colorectal CancerPhase 2/3SUNRISE-CRCNCT03909724
Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)
A Phase 2/3 study testing Sunitinib Malate and TAS 102 in people with Colorectal Cancer and Metastasis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastasis
- What is being tested?
- Sunitinib Malate and TAS 102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2019to 1 Jul 2022
- Phase
- Phase 2/3
- 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
- Signed (by the patient or legally acceptable representative) and dated Informed Consent Form (ICF).
- Histological or cytological confirmed, documentation of incurable locally advanced or metastatic, colorectal adenocarcinoma, not amenable for potentially curative treatment (i.e. inoperable).
- Indication for treatment with TAS-102; progressive on (or intolerant to) therapy including fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)).
- Evaluable disease by RECIST version 1.1 criteria (see appendix III).
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 3.
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- Normal 12-lead ECG (clinically insignificant abnormalities permitted).
- No signs of clinical thyroid abnormalities (suppletion or blocking drugs permitted).
- Adequate bone marrow function
- Adequate liver function
- Albumin higher than 25 g per L
- Serum creatinine ≤1.5 x ULN
- Pregnant or breast-feeding subjects: Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. For fertile men or women of childbearing potential: documented willingness to use a highly effective means of contraception (e.g., hormonal methods [implants, injectables, or combined oral contraceptives], intrauterine devices, sexual abstinence, or vasectomized or surgically sterilized partner). Contraception is necessary for at least 6 months after receiving the study medication.
Who cannot join
- Previous treatment with sunitinib and/or TAS-102 for mCRC.
- Evidence of significant uncontrolled concomitant disease, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmia, clinically significant valvular heart disease and unstable angina); pulmonary disease (including obstructive pulmonary disease > GOLD 2 and inadequately treated symptomatic bronchospasm), and uncontrolled central nervous system, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture.
- Extensive prior radiotherapy in the rectum, pelvis or in more than 3 vertebrae in the spine (less than 3 vertebrae are considered a small radiation field and eligibility will be decided on an individual basis from the PI).
- Poorly controlled hypertension despite adequate blood pressure medication. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 2 separate measurements.
- Instable seizure disorders requiring anticonvulsant therapy.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery.
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- Uncontrolled bleeding disorders, and/or active bleeding.
- Known active bacterial, viral, fungal, mycobacterial, or other infection. (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds.)
- Known hypersensitivity to sunitinib, TAS-102, or to its excipients.
- Presence of any significant psychiatric disorder(s) that would interfere with the patient's compliance.
- Chemotherapy, radiotherapy, or other anti-cancer therapy within the previous 4 weeks; no nitrosoureas or mitomycin C within the previous 6 weeks; no investigational agents within the previous 4 weeks.
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- Untreated or active central nervous system (CNS) metastases.
- Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline of > 3 loose stools daily despite medication.
- Unresolved bowel obstruction
- Any evidence of a disease or condition that might affect compliance with the protocol or interpretation of the study results or render the patient at high risk from treatment complications.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud UMC
Nijmegen, 6525 GA
Sophie Gerritse, MD, sophie.gerritse@radboudumc.nl
About this study
Official title: A Randomized Phase II Study of Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)
The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.
Read the detailed description
Study design: A prospective, open-label, randomized, mono-center, phase II clinical trial (with registration intent).
Hypothesis: The investigators hypothesize a clinically relevant increase in PFS by 3 months; from 2 months as reported for TAS-102 to 5 months in patients treated with sunitinib. They further hypothesize that this will result in a meaningful improvement in Quality of Life (QoL).
Primary Objective: The primary objective of this study is to improve progression free survival (PFS), of patients with metastatic colorectal carcinoma (mCRC) treated with high-dose sunitinib once every 2 weeks to 5 months, compared to the reported 2 months for TAS-102 monotherapy.
Secondary Objective: Secondary objectives include: overall survival (OS), the safety and efficacy of the treatment, the quality of life in the two study arms, the value of phosphoproteomics as a potential predictive biomarker for response to sunitinib, the potential value of blood markers for molecular diagnostics disease and response monitoring and the sensitivity, specificity.
Study Population: Patients eligible for inclusion are at least 18 years of age, with adequate organ function, who have histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented metastatic disease and have an indication for palliative treatment with TAS102 (refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)). Major exclusion criteria include evidence of significant uncontrolled concomitant disease, previous extensive radiotherapy, recent major surgery or infection, unresolved bowel disorders and poorly controlled hypertension. All patients will provide Informed Consent prior to inclusion in the study and during the course of the trial, all relevant data will be stored in electronic Case Report Forms (eCRF).
Treatment Schedule:
After study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason.
- Conditions
- Colorectal Cancer, Metastasis
- Being tested
- Sunitinib Malate, TAS 102
- Keywords
- colorectal cancer, TAS-102, Sunitinib
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib MalateDrug
Also called Sutent
After study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason.
TAS 102Drug
Also called Lonsurf
After study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason.
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 (Lonsurf) | Active comparator | 35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period. Receives: Drug: TAS 102 |
| High Dose Intermittent Sunitinib | Experimental | 700 mg once every 2 weeks. Receives: Drug: Sunitinib Malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Counting from the date of study inclusion (date of randomization) to the date of progressive disease (or death)
Measured: Counting from the date of study inclusion (date of randomization) to the date of progressive disease or death (1 year follow-up). Analysis after inclusion of 33% of patients (N=20)
Secondary outcomes (4)
Overall Survival (OS)
Overall Survival
Measured: From the date of randomization up to the date of death, assessed up to 12 months. If study medication is discontinued for any reason, survival follow-up takes place every 12 weeks, also assessed up to 12 months
Adverse events (AEs)
Safety and tolerability of the two drugs -
Measured: At the end of the study, after 12 months, the number of participants with adverse events that are related to both treatments will be assessed and compared
Health-related quality of life (HRQoL): European Organisation for Research and Treatment of Cancer Quality of Life questionnaires (EORTC QoL)
European Organisation for Research and Treatment of Cancer Quality of Life questionnaires (EORTC QoL)
Measured: via EORTC questionnaires, which will be filled in every 8-9 weeks (from date of randomization until the date of first documented progression or date of death, assessed up to 3 years). The questionnaires of both treatments will be assessed and compared
Liquid biopsies
Liquid biopsies for circulating blood biomarker analysis including microRNA and platelets containing tumor-derived RNA.
Measured: The specific time points during study treatment are: (1) at baseline; (2) every 2 weeks during treatment (until progression of disease), assessed up to 12 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Oct 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H.M.W. Verheul, Amsterdam UMC, location VUmc
- Investigators
- Henk Verheul, Prof. M.D., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909724
- Sponsor's protocol ID
- NL60716.029.18.
- Acronym
- SUNRISE-CRC
- Status last verified
- Nov 2020
- First submitted
- 14 Dec 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Janssen JBE, Iyer KK, Gerritse SL, Janssen E, Gootjes EC, Labots M, Buffart TE, Wumkes ML, Douma JAJ, Streppel MM, Buffart LM, Jonker MA, van den Hombergh E, van Erp NP, Medema JP, Tauriello DVF, Poel D, Verheul HMW. SUNRISE-CRC: a randomized phase II study of high-dose intermittent sunitinib versus trifluridine/tipiracil in metastatic colorectal carcinoma. Oncologist. 2025 Oct 1;30(10):oyaf288. doi: 10.1093/oncolo/oyaf288.
PubMed 40973474
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)
- ClinicalTrials.gov ID
- NCT03909724
- Acronym / sponsor ID
- SUNRISE-CRC / NL60716.029.18.
- Conditions
- Colorectal Cancer, Metastasis
- Keywords
- colorectal cancer, TAS-102, Sunitinib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 10 Apr 2019 (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 purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.
Detailed description
Study design: A prospective, open-label, randomized, mono-center, phase II clinical trial (with registration intent).
Hypothesis: The investigators hypothesize a clinically relevant increase in PFS by 3 months; from 2 months as reported for TAS-102 to 5 months in patients treated with sunitinib. They further hypothesize that this will result in a meaningful improvement in Quality of Life (QoL).
Primary Objective: The primary objective of this study is to improve progression free survival (PFS), of patients with metastatic colorectal carcinoma (mCRC) treated with high-dose sunitinib once every 2 weeks to 5 months, compared to the reported 2 months for TAS-102 monotherapy.
Secondary Objective: Secondary objectives include: overall survival (OS), the safety and efficacy of the treatment, the quality of life in the two study arms, the value of phosphoproteomics as a potential predictive biomarker for response to sunitinib, the potential value of blood markers for molecular diagnostics disease and response monitoring and the sensitivity, specificity.
Study Population: Patients eligible for inclusion are at least 18 years of age, with adequate organ function, who have histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented metastatic disease and have an indication for palliative treatment with TAS102 (refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)). Major exclusion criteria include evidence of significant uncontrolled concomitant disease, previous extensive radiotherapy, recent major surgery or infection, unresolved bowel disorders and poorly controlled hypertension. All patients will provide Informed Consent prior to inclusion in the study and during the course of the trial, all relevant data will be stored in electronic Case Report Forms (eCRF).
Treatment Schedule:
After study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-102 (Lonsurf) | Active comparator | Drug: TAS 10235 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period. |
| High Dose Intermittent Sunitinib | Experimental | Drug: Sunitinib Malate700 mg once every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed (by the patient or legally acceptable representative) and dated Informed Consent Form (ICF).
- Histological or cytological confirmed, documentation of incurable locally advanced or metastatic, colorectal adenocarcinoma, not amenable for potentially curative treatment (i.e. inoperable).
- Indication for treatment with TAS-102; progressive on (or intolerant to) therapy including fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)).
- Evaluable disease by RECIST version 1.1 criteria (see appendix III).
- Age ≥ 18 years.
Key exclusion criteria (16 listed)
- Previous treatment with sunitinib and/or TAS-102 for mCRC.
- Evidence of significant uncontrolled concomitant disease, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmia, clinically significant valvular heart disease and unstable angina); pulmonary disease (including obstructive pulmonary disease > GOLD 2 and inadequately treated symptomatic bronchospasm), and uncontrolled central nervous system, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture.
- Extensive prior radiotherapy in the rectum, pelvis or in more than 3 vertebrae in the spine (less than 3 vertebrae are considered a small radiation field and eligibility will be decided on an individual basis from the PI).
- Poorly controlled hypertension despite adequate blood pressure medication. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 2 separate measurements.
- Instable seizure disorders requiring anticonvulsant therapy.
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 |
|---|---|---|
| Sunitinib MalateAlso: SutentAfter study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason. | Drug | High Dose Intermittent Sunitinib |
| TAS 102Also: LonsurfAfter study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason. | Drug | TAS-102 (Lonsurf) |
Primary outcome
Progression Free Survival
Time frame: Counting from the date of study inclusion (date of randomization) to the date of progressive disease or death (1 year follow-up). Analysis after inclusion of 33% of patients (N=20)
Counting from the date of study inclusion (date of randomization) to the date of progressive disease (or death)
4 secondary outcomes
Overall Survival (OS)
Time frame: From the date of randomization up to the date of death, assessed up to 12 months. If study medication is discontinued for any reason, survival follow-up takes place every 12 weeks, also assessed up to 12 months
Adverse events (AEs)
Time frame: At the end of the study, after 12 months, the number of participants with adverse events that are related to both treatments will be assessed and compared
Health-related quality of life (HRQoL): European Organisation for Research and Treatment of Cancer Quality of Life questionnaires (EORTC QoL)
Time frame: via EORTC questionnaires, which will be filled in every 8-9 weeks (from date of randomization until the date of first documented progression or date of death, assessed up to 3 years). The questionnaires of both treatments will be assessed and compared
Liquid biopsies
Time frame: The specific time points during study treatment are: (1) at baseline; (2) every 2 weeks during treatment (until progression of disease), assessed up to 12 months .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 40973474Janssen JBE, Iyer KK, Gerritse SL, Janssen E, Gootjes EC, Labots M, Buffart TE, Wumkes ML, Douma JAJ, Streppel MM, Buffart LM, Jonker MA, van den Hombergh E, van Erp NP, Medema JP, Tauriello DVF, Poel D, Verheul HMW. SUNRISE-CRC: a randomized phase II study of high-dose intermittent sunitinib versus trifluridine/tipiracil in metastatic colorectal carcinoma. Oncologist. 2025 Oct 1;30(10):oyaf288. doi: 10.1093/oncolo/oyaf288.
- Individual participant dataSharing planned: Yes
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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.
Henk Verheul, Prof. M.D. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sunitinib Malate and TAS 102 in people with Colorectal Cancer and Metastasis, run by Amsterdam UMC, location VUmc 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 13 inclusion and 16 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 13 Nov 2020. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Sophie Gerritse, M.D (+31 (0)6 21 000 286, sophie.gerritse@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Counting from the date of study inclusion (date of randomization) to the date of progressive disease or death (1 year follow-up). Analysis after inclusion of 33% of patients (N=20)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909724, which also lists 1 linked publication.
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 13 Nov 2020.