Rectal AdenocarcinomaPhase 1NCT04104139
TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer
A Phase 1 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Trifluridine and Tipiracil Hydrochloride in people with Rectal Adenocarcinoma and Stage IIA Rectal Cancer AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8
- What is being tested?
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Trifluridine and Tipiracil Hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2019to 15 Jul 2025
- Phase
- Phase 1
- 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
- All races and ethnic groups will be included
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Clinical stage II (T3-4aN0M0) and stage III (T1-4aN1+M0) based on MRI
- Resectable primary rectal tumor at baseline
- No evidence of distant metastases
- No prior pelvic radiation therapy
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- No prior chemotherapy or surgery for rectal cancer
- No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Hemoglobin >= 9.0 gm/dL
- Platelets >= 100,000/uL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)
- Creatinine within normal institutional limits, OR creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A female of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used starting from trial screening and must be continued throughout the study
- Females of childbearing potential must agree to use effective contraceptive method starting with the first dose of study therapy through 6 months after the last dose of study therapy
- Male participants must agree to use an effective method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy
- Participants must read, have the ability to understand, agree to, and sign a statement of Informed Consent prior to participation in this study
- Participants must, as part of their planned treatment per institutional guidelines, be:
- Scheduled to receive preoperative FOLFOX or CAPOX chemotherapy, which requires a central venous access device for administration
- Able to undergo planned TME of the rectal tumor per institutional standards
Who cannot join
- Recurrent rectal cancer
- Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs (T4b disease) and an en bloc resection will not achieve negative margins. Rectal cancer presenting with concurrent or overlapping sites in the colon is eligible if these sites could be removed with surgery
- Distant nodal disease (retroperitoneal nodes), or any metastatic disease by computed tomography (CT) or positron emission tomography (PET)
- Creatinine > 1.5 x ULN
- History of peripheral neuropathy > grade 2
- History of malabsorption syndromes or inflammatory bowel disease
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- Use of immunosuppressive or myelosuppressive medications including but not limited to adalimumab, azathioprine, BCG, clozapine, cyclosporine, deferiprone, etanercept, fingolimod, hydroxyurea, interferon, leflunomide, methotrexate, mycophenolate, natalizumab, pimecrolimus, rituximab, sirolimus, and tacrolimus
- Inability to take oral medications
- Participants who received prior pelvic radiotherapy
- Use of induction chemotherapy prior to chemo-radiation of rectal cancer
- Use of other chemotherapy regimens other than FOLFOX or CAPOX
- Participants who are unable to undergo an MRI
- Participants who are unable to undergo TME
- Refusal of standard-of-care TME of the rectal tumor if there is persistent disease after neoadjuvant treatment
- Participants with a history of any arterial thrombotic event within the past 6 months, including angina (stable or unstable), myocardial infarction (MI), transient ischemic attack (TIA), or cerebrovascular accident (CVA)
- Participants with a recent history of venous thrombotic episodes such as deep venous thrombosis and pulmonary embolism within the past 3 months. If these episodes occurred more than three months prior to enrollment, they may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, participants who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy
- Febrile illness within 7 days of study enrollment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102 or other agents used in this study
- Other anticancer or experimental therapy. No other experimental therapies including for other disease indications are allowed while the participant is receiving study treatment
- Women who are pregnant or breast-feeding
- Participants with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study
- Participants with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Phase 1b Study to Assess the Safety of Neoadjuvant TAS-102 (Trifluridine/Tipiracil) With Concurrent Radiation in Previously Untreated Resectable Stage II and Stage III Rectal Cancer (FIERCE)
This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out the safest dose of TAS-102 that can be used with radiation treatment for rectal cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the recommended phase 2 dose of trifluridine and tipiracil hydrochloride (TAS-102) per the proportion of grade 3 or higher adverse events during chemo-radiation therapy (CRT) with concurrent TAS-102 at the maximum tolerated dose by allowing no more than 30% grade 3 or higher adverse events.
SECONDARY OBJECTIVES:
- Evaluate safety of participants treated with TAS-102 during radiation therapy (RT).
II. Evaluate treatment emergent adverse events (TEAEs) attributable to TAS-102 with RT during fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or capecitabine/oxaliplatin (CAPOX) treatment.
EXPLORATORY OBJECTIVES:
- To preliminary assess the rates of complete clinical response (cCR) by magnetic resonance imaging (MRI) and by endoscopy after TAS-102 with concurrent CRT.
II. To preliminary assess the rates of cCR by MRI and by endoscopy after treatment with FOLFOX.
III. To preliminary assess the rates of pCR after standard total mesorectal excision (TME).
OUTLINE: This is dose-escalation study of TAS-102.
Patients receive TAS-102 orally (PO) twice daily (BID) Monday-Friday on weeks 1, 3, and 5. Patients also undergo intensity modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) 5 days per week on weeks 1-5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care FOLFOX or CAPOX.
After completion of study treatment, patients are followed for up to a total of 16 weeks (3 months) from end of FOLFOX or CAPOX treatment until rectal cancer surgery or death, whichever occurs first. Participants that opt for a non-surgical option at the end of chemotherapy may be followed for a longer period of time.
- Conditions
- Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8
- Being tested
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Trifluridine and Tipiracil Hydrochloride
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT
Undergo 3D-CRT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Undergo IMRT
Trifluridine and Tipiracil HydrochlorideDrug
Also called Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TAS-102, IMRT, 3D-CRT) | Experimental | Patients receive TAS-102 PO BID Monday-Friday on weeks 1, 3, and 5. Patients also undergo IMRT or 3D-CRT 5 days per week on weeks 1-5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care FOLFOX or CAPOX. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Drug: Trifluridine and Tipiracil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of dose limiting toxicity (DLT)s for TAS-102 at the maximum tolerated dose (MTD)
Will be assessed through the Bayesian optimal interval design and will be determined by the proportion of grade 3 or higher adverse events during chemo-radiation therapy (CRT) with TAS-102 at the MTD by allowing no more than 30% DLT. The proportion will be descriptively noted.
Measured: Up to end of week 8, or start of fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or capecitabine/oxaliplatin (CAPOX) chemotherapy, whichever occurs first
Secondary outcomes (2)
Incidence of adverse events (AEs) (all grade) for TAS-102 concurrent with radiation therapy (RT)
Descriptive statistics of safety will be presented using National cancer Institute Common Terminology Criteria for Adverse Events version 5.0., with AEs tabulated by the MedDRA preferred term and system organ class. The incidence of AEs (all grades) for TAS-102 with concurrent RT will be assessed using the CRT analysis set.
Measured: Up to start of FOLFOX or CAPOX (up to 8 weeks)
Incidence of grade 3 or higher treatment emergent adverse events (TEAEs) during FOLFOX or CAPOX treatment
The incidence of grade 3 or higher TEAEs during FOLFOX or CAPOX chemotherapy will be assessed using the FOLFOX/CAPOX analysis set.
Measured: Up to end of FOLFOX or CAPOX (up to 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start11 Dec 2019
- Primary completion25 Sep 2024
- Study completion15 Jul 2025
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 Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Charles D Lopez, OHSU Knight Cancer Institute
- Investigators
- Charles D Lopez, MD, PhD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104139
- Sponsor's protocol ID
- STUDY00019576
- Other IDs
- NCI-2019-06387, SOL-19069-L, STUDY00019576
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chen EY, Nabavizadeh N, Kendsersky ND, Lessenich C, Herzig DO, Korngold E, Goodyear SM, Kennecke HF, Kardosh A, Tsikitis VL, Lu KC, Fang S, Wong M, Pegna GJ, Rocha FG, Mayo SC, Brinkerhoff B, Taber E, Rajagopalan B, Park BS, Thomas CR Jr, Lopez CD. Phase Ib Study to Assess the Safety of Neoadjuvant Trifluridine/Tipiracil With Concurrent Radiation in Resectable Stage II/III Rectal Cancer: The FIERCE Study. Clin Colorectal Cancer. 2026 Jun;25(2):249-257.e2. doi: 10.1016/j.clcc.2026.02.001. Epub 2026 Feb 4.
PubMed 41781240
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study to Assess the Safety of Neoadjuvant TAS-102 (Trifluridine/Tipiracil) With Concurrent Radiation in Previously Untreated Resectable Stage II and Stage III Rectal Cancer (FIERCE)
- ClinicalTrials.gov ID
- NCT04104139
- Acronym / sponsor ID
- STUDY00019576
- Conditions
- Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, Taiho Pharmaceutical Co., Ltd.
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 26 Sep 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.
This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out the safest dose of TAS-102 that can be used with radiation treatment for rectal cancer.
Detailed description
PRIMARY OBJECTIVE:
- To determine the recommended phase 2 dose of trifluridine and tipiracil hydrochloride (TAS-102) per the proportion of grade 3 or higher adverse events during chemo-radiation therapy (CRT) with concurrent TAS-102 at the maximum tolerated dose by allowing no more than 30% grade 3 or higher adverse events.
SECONDARY OBJECTIVES:
- Evaluate safety of participants treated with TAS-102 during radiation therapy (RT).
II. Evaluate treatment emergent adverse events (TEAEs) attributable to TAS-102 with RT during fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or capecitabine/oxaliplatin (CAPOX) treatment.
EXPLORATORY OBJECTIVES:
- To preliminary assess the rates of complete clinical response (cCR) by magnetic resonance imaging (MRI) and by endoscopy after TAS-102 with concurrent CRT.
II. To preliminary assess the rates of cCR by MRI and by endoscopy after treatment with FOLFOX.
III. To preliminary assess the rates of pCR after standard total mesorectal excision (TME).
OUTLINE: This is dose-escalation study of TAS-102.
Patients receive TAS-102 orally (PO) twice daily (BID) Monday-Friday on weeks 1, 3, and 5. Patients also undergo intensity modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) 5 days per week on weeks 1-5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care FOLFOX or CAPOX.
After completion of study treatment, patients are followed for up to a total of 16 weeks (3 months) from end of FOLFOX or CAPOX treatment until rectal cancer surgery or death, whichever occurs first. Participants that opt for a non-surgical option at the end of chemotherapy may be followed for a longer period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TAS-102, IMRT, 3D-CRT) | Experimental | Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Drug: Trifluridine and Tipiracil HydrochloridePatients receive TAS-102 PO BID Monday-Friday on weeks 1, 3, and 5. Patients also undergo IMRT or 3D-CRT 5 days per week on weeks 1-5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care FOLFOX or CAPOX. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- All races and ethnic groups will be included
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Clinical stage II (T3-4aN0M0) and stage III (T1-4aN1+M0) based on MRI
- Resectable primary rectal tumor at baseline
- No evidence of distant metastases
Key exclusion criteria (22 listed)
- Recurrent rectal cancer
- Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs (T4b disease) and an en bloc resection will not achieve negative margins. Rectal cancer presenting with concurrent or overlapping sites in the colon is eligible if these sites could be removed with surgery
- Distant nodal disease (retroperitoneal nodes), or any metastatic disease by computed tomography (CT) or positron emission tomography (PET)
- Creatinine > 1.5 x ULN
- History of peripheral neuropathy > grade 2
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 |
|---|---|---|
| 3-Dimensional Conformal Radiation TherapyAlso: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRTUndergo 3D-CRT | Radiation | Treatment (TAS-102, IMRT, 3D-CRT) |
| Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated RadiotherapyUndergo IMRT | Radiation | Treatment (TAS-102, IMRT, 3D-CRT) |
| Trifluridine and Tipiracil HydrochlorideAlso: Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with TrifluridineGiven PO | Drug | Treatment (TAS-102, IMRT, 3D-CRT) |
Primary outcome
Proportion of dose limiting toxicity (DLT)s for TAS-102 at the maximum tolerated dose (MTD)
Time frame: Up to end of week 8, or start of fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or capecitabine/oxaliplatin (CAPOX) chemotherapy, whichever occurs first
Will be assessed through the Bayesian optimal interval design and will be determined by the proportion of grade 3 or higher adverse events during chemo-radiation therapy (CRT) with TAS-102 at the MTD by allowing no more than 30% DLT. The proportion will be descriptively noted.
2 secondary outcomes
Incidence of adverse events (AEs) (all grade) for TAS-102 concurrent with radiation therapy (RT)
Time frame: Up to start of FOLFOX or CAPOX (up to 8 weeks)
Incidence of grade 3 or higher treatment emergent adverse events (TEAEs) during FOLFOX or CAPOX treatment
Time frame: Up to end of FOLFOX or CAPOX (up to 16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 41781240Chen EY, Nabavizadeh N, Kendsersky ND, Lessenich C, Herzig DO, Korngold E, Goodyear SM, Kennecke HF, Kardosh A, Tsikitis VL, Lu KC, Fang S, Wong M, Pegna GJ, Rocha FG, Mayo SC, Brinkerhoff B, Taber E, Rajagopalan B, Park BS, Thomas CR Jr, Lopez CD. Phase Ib Study to Assess the Safety of Neoadjuvant Trifluridine/Tipiracil With Concurrent Radiation in Resectable Stage II/III Rectal Cancer: The FIERCE Study. Clin Colorectal Cancer. 2026 Jun;25(2):249-257.e2. doi: 10.1016/j.clcc.2026.02.001. Epub 2026 Feb 4.
- Related InfoLink provided by the sponsor.
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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.
Charles D Lopez, MD, PhD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Trifluridine and Tipiracil Hydrochloride in people with Rectal Adenocarcinoma and Stage IIA Rectal Cancer AJCC v8, run by OHSU Knight Cancer Institute 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 23 inclusion and 22 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: finished, as of the sponsor's last update on 6 Aug 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of dose limiting toxicity (DLT)s for TAS-102 at the maximum tolerated dose (MTD) (time frame: Up to end of week 8, or start of fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or capecitabine/oxaliplatin (CAPOX) chemotherapy, whichever occurs first). 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 NCT04104139, 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 6 Aug 2026.