Colon CancerPhase 2SCOTINCT05806931
Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
A Phase 2 study testing TAS-102, oxaliplatin, irinotecan with bevacizumab in people with Colon Cancer and Rectal Cancer, run by Rutgers, The State University of New Jersey at 9 sites in United States.
Trial summary
This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- TAS-102, oxaliplatin, irinotecan with bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 May 2023to 1 May 2027
- 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
- Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate.
- Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease.
- Progression of disease must be documented on the most recent scan.
- Presence of measurable disease
- RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined).
- Age 18 years or older.
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- ECOG performance status 0-1.
- Life expectancy of at least three months.
- Participants with adequate organ function:
- Absolute neutrophil count (ANC) > 1.5 x 109/L
- Hemoglobin > 9 g/dL
- Platelets (PLT) > 70 x 109/L
- AST/ALT < 5 x ULN
- Albumin within normal limits for institution
- Women who are nursing and discontinue nursing prior to enrollment in the program.
- Ability to take oral medication (i.e., no feeding tube).
- Participant able and willing to comply with study procedures as per protocol.
- Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.
Who cannot join
- Participants who have previously received TAS-102.
- Grade 3 or higher peripheral neuropathy (functional impairment).
- Inability to tolerate irinotecan previously (due to uncontrolled diarrhea)
- There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is >1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab.
- Symptomatic CNS metastases requiring treatment.
- Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer).
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- Pregnancy or breast feeding.
- Current therapy with other investigational agents.
- Active infection with body temperature > 38°C due to infection.
- Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration).
- Any anticancer therapy within prior two weeks of first dose of study drug.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102.
- Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks.
- Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication.
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202
Howard S. Hochster, MD, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
Howard S. Hochster, MD, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Howard S. Hochster, MD, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Livingston, New Jersey, 07039
Howard S. Hochster, MD, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
Howard S. Hochster, MD, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Howard S. Hochster, MD, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Howard S. Hochster, MD, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08873
Howard S. Hochster, 732-253-5618, howard.hochster@rutgers.edu
- Recruiting
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
Howard S. Hochster, 732-253-5618, howard.hochster@rutgers.edu
About this study
Official title: Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line Metastatic Colorectal Cancer
This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)
Read the detailed description
This phase II trial will evaluate efficacy of TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC. Participants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- TAS-102, oxaliplatin, irinotecan with bevacizumab
- Keywords
- Sequential Combined TAS-102, Oxaliplatin, Irinotecan, Late-Line Metastatic Colorectal Cancer, Bevacizumab
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102, oxaliplatin, irinotecan with bevacizumabDrug
Participants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events. TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC.
| Study group | Role | What they receive |
|---|---|---|
| Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab | Experimental | Each treatment cycle will be fourteen days long. TAS-102 25 mg/m2 will be taken orally twice daily on days 1-5 of each cycle. Oxaliplatin 85 mg/m2 infusion will be given on day one for one cycle alternating with Irinotecan 150 mg/m2 infusion, which will be given on day one the next cycle. Receives: Drug: TAS-102, oxaliplatin, irinotecan with bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR):
Defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD). The disease control rate will be calculated along with 95% confidence interval. As Simon's two stage design is used in the study, 95% CI will be calculated for the two-stage nature of the study design. Response will be determined by independent radiologists using the RECIST criteria.
Measured: From baseline until the date of first documented progression of disease, as assessed up to 100 months
Secondary outcomes (4)
Progression Free Survival (PFS)
Progression Free Survival (PFS) Progression will be assessed by a CT scan according to RECIST criteria version 1.1. This criterion will be estimated by the median time based on a Kaplan-Meier method. Patients who have not progressed or died at the time of analysis will be censored at the time of their latest follow-up with clinically stable disease. This includes participants who withdraw consent.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 100 months
Overall Survival (OS)
This will be analyzed and plotted using the Kaplan-Meier method.
Measured: From date of randomization until the date of death up to 100 months
Overall Response Rate (ORR)
This will be calculated along with 95% confidence interval.
Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per RECIST criteria, version 1.1. A maximum of five measurable lesions in total (and up to 2 per organ) representative of all involved organs should be identified as target lesions at baseline and measured through the course of study treatment. At baseline, the sum of the diameters (longest diameters (LD) for extra nodal target lesions and short axis diameters (SAD) for nodal lesions) will be calculated and reported as the baseline sum LD. This baseline sum LD will be used as the reference by which to characterize the objective tumor response. All other lesions should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout the study
Measured: From the date of randomization and measured through the course of study treatment, assessed up to 100 months
Duration of Response
Response will be determined by independent radiologist using RECIST 1.1. Time to progression for responders will be analyzed by Kaplan-Meier methods.
Measured: From the date of response until the date of first documented disease progression or death, assessed up to 100 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 2023
- Study start17 May 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard S. Hochster, MD, Rutgers, The State University of New Jersey
- Investigators
- Howard S. Hochster, MD, Principal investigator, Cancer Institute of New Jersey Rutgers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806931
- Sponsor's protocol ID
- 072303
- Other IDs
- Pro2023000358
- Acronym
- SCOTI
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05806931
- Acronym / sponsor ID
- SCOTI / 072303
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Sequential Combined TAS-102, Oxaliplatin, Irinotecan, Late-Line Metastatic Colorectal Cancer, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 10 Apr 2023 (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 study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)
Detailed description
This phase II trial will evaluate efficacy of TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC. Participants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab | Experimental | Drug: TAS-102, oxaliplatin, irinotecan with bevacizumabEach treatment cycle will be fourteen days long. TAS-102 25 mg/m2 will be taken orally twice daily on days 1-5 of each cycle. Oxaliplatin 85 mg/m2 infusion will be given on day one for one cycle alternating with Irinotecan 150 mg/m2 infusion, which will be given on day one the next cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate.
- Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease.
- Progression of disease must be documented on the most recent scan.
- Presence of measurable disease
- RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined).
Key exclusion criteria (15 listed)
- Participants who have previously received TAS-102.
- Grade 3 or higher peripheral neuropathy (functional impairment).
- Inability to tolerate irinotecan previously (due to uncontrolled diarrhea)
- There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is >1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab.
- Symptomatic CNS metastases requiring treatment.
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 |
|---|---|---|
| TAS-102, oxaliplatin, irinotecan with bevacizumabParticipants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events. TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC. | Drug | Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab |
Primary outcome
Disease control rate (DCR):
Time frame: From baseline until the date of first documented progression of disease, as assessed up to 100 months
Defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD). The disease control rate will be calculated along with 95% confidence interval. As Simon's two stage design is used in the study, 95% CI will be calculated for the two-stage nature of the study design. Response will be determined by independent radiologists using the RECIST criteria.
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 100 months
Overall Survival (OS)
Time frame: From date of randomization until the date of death up to 100 months
Overall Response Rate (ORR)
Time frame: From the date of randomization and measured through the course of study treatment, assessed up to 100 months
Duration of Response
Time frame: From the date of response until the date of first documented disease progression or death, assessed up to 100 months
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 18 Mar 2026.
- 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.
Howard S. Hochster, MD principal investigator
Cancer Institute of New Jersey Rutgers
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-102, oxaliplatin, irinotecan with bevacizumab in people with Colon Cancer and Rectal Cancer, run by Rutgers, The State University of New Jersey at 9 sites 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 18 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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 Howard S. Hochster, MD (732-253-5618, howard.hochster@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR): (time frame: From baseline until the date of first documented progression of disease, as assessed up to 100 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 18 Mar 2026.