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Metastatic Colorectal CancerPhase 2SOREGATTNCT04450836

Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer

A Phase 2 study testing Regorafenib then Trifluridine/Tipiracil and Trifluridine/Tipiracil then Regorafenib in people with Metastatic Colorectal Cancer, run by UNICANCER at 36 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer 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?
Regorafenib then Trifluridine/Tipiracil and Trifluridine/Tipiracil then Regorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
36 sitesin 2 countries
Study dates
23 Nov 2020to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have provided informed consent before performing any study specific procedures.
  • Histological or cytological documented adenocarcinoma of the colon or rectum.
  • Patients with metastatic colorectal cancer (stage IV).
  • Measurable disease, defined as at least one unidimensional measurable lesion on a computed tomography (CT) scan according to RECIST v1.1.
  • The patient must have progressed following exposure of all the following agents : one fluoropyrimidine-based chemotherapy (capecitabine or fluorouracil [5-FU], combined with oxaliplatin and/or irinotecan (including FOLFOX, FOLFIRI or FOLFOXIRI) as well as EGFR and/or VEGF inhibitors in patients eligible for these treatments.
  • Patients considered eligible for treatment with both regorafenib and trifluridine-tipiracil.
Show all 19Show fewer
  • Male or female patients aged ≥18 years.
  • ECOG performance status of ≤1.
  • Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements:
  • Total bilirubin ≤1.5 x upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN (≤5 x ULN for patients with liver metastasis).
  • Alkaline phosphatase limit ≤2.5 x ULN (≤5 x ULN for patients with liver metastasis).
  • Serum creatinine ≤1.5 x ULN.
  • International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5 x ULN. Patients receiving anticoagulants, such as warfarin or heparin are eligible if there is no prior evidence of an underlying abnormality with coagulation.
  • Platelet count ≥75000 /mm³, hemoglobin (Hb) ≥9 g/dL, absolute neutrophil count (ANC) ≥1500/mm³. Blood transfusions to meet this inclusion criterion are not allowed.
  • Women of childbearing potential and men must agree to use a highly effective contraception (1% failure rate) from the signing of the informed consent form until at least 6 months after the last study drug administration. Women using hormonal contraceptive must also use a barrier method.
  • Women of childbearing potential must have a negative pregnancy test within 7 days before starting study treatment.
  • Patients affiliated to the social security system.
  • Patient willing and able to comply with the protocol for the duration of the study including treatment, scheduled visits, and examinations throughout the study, including follow up.

Who cannot join

  • Patients with symptomatic brain or meningeal metastasis, unless definitive therapy occurred more than 6 months ago and with a confirmation of tumoral control within 4 weeks of starting study treatment.
  • Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to study inclusion, except for curatively treated in situ cervical cancer, non-melanoma skin cancer, and superficial bladder tumors: staged Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor with lamina propria invasion).
  • Prior treatment with regorafenib or any other tyrosine kinase inhibitor.
  • Prior treatment with trifluridine/tipiracil.
  • Known hypersensitivity to any of the study drugs, study drug classes, or study drug excipients.
  • Unresolved toxicity grade >1 (by CTCAE v5.0) caused by prior therapy/procedure, excluding alopecia, hypothyroidism, and oxaliplatin-induced neurotoxicity grade ≤2.
Show all 32Show fewer
  • Patient with moderate or severe hepatic impairment (Child-Pugh C).
  • Known UGT1A1 polymorphisms. History of Gilbert's syndrome.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before starting study treatment.
  • Chemotherapy within 21 days of starting study treatment.
  • Radiotherapy within 4 weeks of starting study treatment, except for palliative radiotherapy within 2 weeks.
  • Active cardiac disease including any of the Following:
  • Congestive heart Failure: New York Heart Association (NYHA) class ≥2.
  • Unstable angina (angina symptoms at rest), or a new-onset angina (within the 3 months before enrolment).
  • Myocardial infarction that occurred less than 6 months before enrolment.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy (treatment with beta blockers or digoxin are permitted)
  • Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite treatment).
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of starting study treatment.
  • Ongoing infection grade 2 (CTCAE v5.0).
  • Known history of human immunodeficiency virus (HIV) infection.
  • Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
  • Patients with seizure disorder requiring medication.
  • Patients with a history of any bleeding diathesis, irrespective of the severity.
  • Any hemorrhage or bleeding event grade ≥3 (CTCAE v5.0) within 4 weeks before starting study treatment.
  • Presence of a wound, ulcer, or bone fracture that is not healing.
  • Patients unable to swallow oral medications.
  • Bowel malabsorption or extended bowel resection that could affect the absorption of regorafenib, occlusive syndrome.
  • Presence of gastro-intestinal fistula or perforation.
  • Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and their compliance in the study.
  • Patients participating in another therapeutic study within the 30 days before enrolment.
  • Pregnant or breast feeding women.
  • Person deprived of their liberty or under protective custody or guardianship.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

France33 sites

  • Hôpital Privé Pays de Savoie

    Annemasse

  • Centre hospitalier d'Auxerre

    Auxerre

  • Institut Sainte Catherine

    Avignon, 84000

  • Centre Hospitalier de Bayeux

    Bayeux

  • Centre François Baclesse

    Caen

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300

  • CH Cotentin

    Cherbourg, 50102

  • Institut de Cancérologie de Bourgogne

    Dijon, 21000

  • Centre Oscar Lambret

    Lille

  • Hôpital Scorff

    Lorient, 56322

  • Centre Léon Bérard

    Lyon

  • Association Hôpital Saint Joseph de Marseille

    Marseille, 13008

  • Hôpital privé du Confluent

    Nantes, 44277

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hôpital Privé des Peupliers

    Paris, 75013

  • APHP - Hôpital Européen Georges Pompidou

    Paris

  • Groupe hospitalier Pitié Salpétrière

    Paris

  • CH Périgueux

    Périgueux, 24000

  • CH Saint Jean

    Perpignan

  • CHU de Bordeaux - Hôpital Haut Lévèque

    Pessac

  • Hôpital Privé des Côtes d'Armor - Centre CARIO-HPCA

    Plérin

  • CHU de Poitiers

    Poitiers

  • CHU - Robert Debre

    Reims, 51092

  • Institut Jean Godinot

    Reims

  • Hopital Charles Nicolle

    Rouen

  • CHU Hôpital Nord

    Saint-Etienne, 42270

  • Centre Hospitalier de Saint Malo

    St-Malo

  • Centre Paul Strauss (ICANS)

    Strasbourg

  • CHU de Toulouse

    Toulouse, 31059

  • Centre Hospitalier de Valence

    Valence, 26000

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Paul Brousse

    Villejuif, 94800

  • Gustave Roussy

    Villejuif

Other trials in France

Belgium3 sites

  • Clinique Saint Luc

    Bouge, 5004

  • CH de l'Ardenne

    Libramont, 6800

  • CH Verviers

    Verviers, 4800

Other trials in Belgium

About this study

Official title: A Randomized, Phase II Study Comparing the Sequences of Regorafenib and Trifluridine/Tipiracil, After Failure of Standard Therapies in Patients With Metastatic Colorectal Cancer

A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer

Read the detailed description

Multicenter, international, comparative, randomized, open-label, phase II study conducted in two parallel groups.

The study population will consist of male and female patients aged ≥18 years old with metastatic colorectal cancer after failure of fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapies, as well as epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) inhibitors in patients eligible for these treatments.

Patients will be randomized according to a 1:1 ratio to treatment arms A and B.

  • Arm A: regorafenib until disease progression or unacceptable toxicity occurs, followed by trifluridine/tipiracil until disease progression or unacceptable toxicity occurs.
  • Arm B: trifluridine/tipiracil until disease progression or unacceptable toxicity occurs, followed by regorafenib until disease progression or unacceptable toxicity occurs.
Being tested
Regorafenib then Trifluridine/Tipiracil, Trifluridine/Tipiracil then Regorafenib
Keywords
Regorafenib, Trifluridine/Tipiracil, Metastatic colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regorafenib then Trifluridine/TipiracilDrug

    Also called STIVARGA, LONSURF

    REGORAFENIB 160 mg per day during 3 weeks followed by 1 week off of each 4-week cycle except for cycle 1.

    During first cycle: dose is started at 80 mg per day at week 1, 120 mg per day at week 2, 160 mg per day at week 3, followed by 1 week off.

    Then TRIFLURIDINE/TIPIRACIL 35 mg/m² Dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 4-week cycle.

  • Trifluridine/Tipiracil then RegorafenibDrug

    Also called LONSURF, STIVARGA

    TRIFLURIDINE/TIPIRACIL 35 mg/m² Dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 4-week cycle.

    Then REGORAFENIB 160 mg per day during 3 weeks followed by 1 week off of each 4-week cycle except for cycle 1.

    During first cycle: dose is started at 80 mg per day at week 1, 120 mg per day at week 2, 160 mg per day at week 3, followed by 1 week off.

Study groups in NCT04450836
Study groupRoleWhat they receive
Arm A (R-TT)ExperimentalRegorafenib followed by trifluridine-tipiracil.
Receives: Drug: Regorafenib then Trifluridine/Tipiracil
Arm B (TT-R)ExperimentalTrifluridine-tipiracil followed by Regorafenib.
Receives: Drug: Trifluridine/Tipiracil then Regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the feasibility of treatment sequence (R-TT or TT-R)

    The feasibility of the treatment sequence is defined as the percentage of subjects able to receive both regorafenib and trifluridine/tipiracil according to the sequence in 3rd and 4th line. Subjects will be considered as having received both 3rd and 4th lines if they are administered at least two cycles of each line of therapy, i.e. percentage of patients being treated until the first tumor evaluation.

    Measured: Expected duration of 5 months from randomization

Secondary outcomes (10)

  1. To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of Overall Survival rate

    Overall Survival (OS) is defined as the time interval from randomization until death from any cause.

    Measured: Expected duration of 9 months from randomization

  2. To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the progression-free Survival 1 (PFS1)

    Progression-free survival 1 (PFS1) is defined as the time interval from randomization until death or the disease progression observed in the first sequence of treatment in each arm, evaluated using Response evaluation criteria in solid tumors (RECIST) v1.1.

    Measured: Expected duration of 3 months from randomization

  3. To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Progression-free survival 2 (PFS2)

    Progression-free survival 2 (PFS2) is defined as the time interval from randomization until death or the disease progression is observed in the later sequence of treatment in each arm, evaluated using RECIST v1.1.

    Measured: Expected duration of 6 months from randomization

  4. To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Disease control rate (DCR)

    Disease control rate (DCR) is defined as percentage of patients with a best response that is not progressive disease (PD) (either complete response [CR], partial response [PR], or stable disease [SD]) during treatment. DCR will be assessed in each study arm.

    Measured: Expected duration of 6 months from randomization

  5. To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Objective response rate (ORR)

    Objective response rate (ORR) is defined as percentage of patients with a best response being either complete response [CR] or partial response [PR] during treatment. ORR will be assessed in each study arm.

    Measured: Expected duration of 6 months from randomization

  6. To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Time-to-treatment failure 1 (TTF1)

    Time-to-treatment failure 1 (TTF1) is defined as the time from randomization to treatment discontinuation for any reason (including disease progression, treatment toxicity, patient preference, or death) during the first sequence of treatment in each arm.

    Measured: Expected duration of 3 months from randomization

  7. To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Time-to-treatment failure 2 (TTF2)

    Time-to-treatment failure 2 (TTF2) is defined as the time from randomization to treatment discontinuation for any reason (including disease progression, treatment toxicity, patient preference, or death) during the second sequence of treatment in each arm.

    Measured: Expected duration of 6 months from randomization

  8. To evaluate the health-related quality of life of cancer patients during treatment

    Quality of life data using the patient reported outcomes, quality of life questionnaire - Core 30 (QLQ-C30) version 3.0 will be collected during the study.

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: Expected 30 days after last study treatment administration, up to 5 years

  9. To evaluate the performance status deterioration

    The time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 deterioration is defined as the time interval between randomization and the first documented ECOG PS ≥2 during the study.

    Measured: Expected 30 days after last study treatment administration, up to 5 years

  10. To evaluate the safety (Treatment-Emergent Adverse Events) during treatment

    Data concerning adverse events graded using the common terminology criteria for adverse events (CTCAE) v5.0 will be collected during the study.

    Measured: Expected 30 days after last study treatment administration, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start23 Nov 2020
  3. Primary completion23 Mar 2024
  4. Study completion31 Dec 2024

Why it stopped: Following the presentation of the SUNLIGHT study results at ASCO GI and the rapid change in patient management in the majority of centers, the IDMC experts recommended halting inclusion in the SOREGATT study with immediate effect.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450836
Sponsor's protocol ID
UC-GIG-1910
Other IDs
2019-004196-39, PRODIGE 68 - UCGI 38, 2019
Acronym
SOREGATT
Status last verified
Mar 2025
First submitted
24 Jun 2020
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib then Trifluridine/Tipiracil and Trifluridine/Tipiracil then Regorafenib in people with Metastatic Colorectal Cancer, run by UNICANCER at 36 sites in 2 countries.

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 19 inclusion and 32 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: stopped early, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Following the presentation of the SUNLIGHT study results at ASCO GI and the rapid change in patient management in the majority of centers, the IDMC experts recommended halting inclusion in the SOREGATT study with immediate effect.). Results are not available in the source record.

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?

To evaluate the feasibility of treatment sequence (R-TT or TT-R) (time frame: Expected duration of 5 months from randomization). 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 NCT04450836.

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 30 Mar 2025.

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