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Colorectal AdenocarcinomaPhase 2NCT04894123

Cardiovascular Events From Trifluridine/Tipiracil +/- Oxaliplatin in Colorectal/Oesogastric Adenocarcinoma Patients

A Phase 2 study testing Trifluridine/Tipiracil and Oxaliplatin in people with Colorectal Adenocarcinoma and Oesogastric, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 11 sites in France.

Terminated

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

Official record
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Trial summary

The purpose of this study is to assess the incidence of cardiovascular events in patients with esophageal/stomach or colorectal cancer treated by trifluridine/tipiracil +/- oxaliplatin after an episode of cardiac angina-related thoracic pain due to fluoropyrimidines in the adjuvant or metastatic setting . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Adenocarcinoma, Oesogastric
What is being tested?
Trifluridine/Tipiracil and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
11 sitesFrance
Study dates
7 Feb 2022to 13 Feb 2023
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

  • Signed and dated informed consent and willingness to comply with all study procedures and availability for the study duration,
  • Histologically confirmed oesogastric, gastric, colon and/or rectum adenocarcinoma
  • Patients with metastatic non-resectable (oesogastric or colorectal) or adjuvant (colorectal stage III) adenocarcinoma previously treated by fluoropyrimidines (5-FU or capecitabine),
  • Age ≥18 years,
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2,
  • Patients who presented an episode of cardiac angina-related thoracic pain due to 5- FU or capecitabine (minimum 21 days [3 weeks] between event and inclusion) at least one of the following events:
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  • Instable angina,
  • Acute coronary syndrome (ACS) without ST-segment elevation nor troponin rise.
  • Contraindication to continue treatment with 5FU or capecitabine confirmed and documented by a cardiologist,CONFIDENTIAL Protocol ACOTAS version 1.5, 14/06/2021 Page 32 of 93
  • Indication to receive trifluridine/tipiracil ± oxaliplatin considered better than absence of therapy (colo-rectal stage III) or the best alternative therapy (metastatic colo-rectal and oeso-gastric or gastric) confirmed by a Multidisciplinary Consultation Meeting
  • No contraindication to receive trifluridine/tipiracil (related toxicity),
  • No prior treatment with trifluridine/tipiracil,
  • Following laboratory values obtained within 14 days (2 weeks) prior to start of study treatment:
  • Hematological status: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL,
  • Adequate renal function: serum creatinine level < 150 µM and creatinine clearance ≥ 50 ml/min using the Cockroft-Gault formula,
  • Adequate liver function: serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase (ALP) < 5 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN,
  • For female patients of childbearing potential, negative serum pregnancy test within 7 days (1 week) prior starting the study treatment,
  • Female patients of childbearing potential must commit to using reliable and effective methods of contraception during the trial and until at least 12 months after the end of study treatment. Male patients with a partner of childbearing potential must agree to use effective contraception in addition to the contraceptive method used by their partner during the trial and until at least 9 months after the end of study treatment.
  • Registration in a national health care system (PUMa - Protection Universelle Maladie included)

Who cannot join

  • For metastatic colo-rectal-cancer, MSI and/or dMMR tumor
  • For metastatic oeso-gastric and gastric adenocarcinoma, HER+++ or HER++ FISH positive tumor
  • Left ventricular dysfunction with a left ventricular ejection fraction (LVEF) < 35% with or without an automatic implantable defibrillator,
  • Non-revascularized multivessel coronary artery disease,
  • ACS with ST elevation, and/ or troponin rise
  • QT/QTc interval > 470 ms (for women) and > 450 ms (for men) NB: Caution is required when using medicinal products with human thymidine kinase substrates, e.g. zidovudine and other drugs known to prolong the QTc interval (exhaustive list on https: //www.crediblemeds.org.")
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  • Documented coronary vasospasm during 5-FU treatment leading to myocardial infarction,
  • Pregnancy and breastfeeding,
  • Treatment with any other investigational medicinal product within 28 days (4 weeks) before start of the study treatment,
  • Rare hereditary problems of galactose intolerance, the Lapp lactose deficiency, or glucose-galactose malabsorption,
  • Any other serious and uncontrolled non-malignant disease,
  • Major surgery or traumatic injury within 28 days (4 weeks) before the start of study treatment,
  • Patients with known allergy to any excipient to study drugs,
  • Bowel obstruction or inability to swallow tablets,
  • Peripheral neuropathy Grade > 1 for the oxaliplatin schedule,
  • Non resolved non-hematological toxicities from prior therapies (grade >2),
  • Abnormal values at inclusion for :
  • kalemia ;
  • Magnesemia;
  • Calcemia and corrected calcium level
  • Patient under a legal protection regime (guardianship, curatorship, judicial safeguard), or administrative decision, or incapable of giving his/her consent
  • Impossibility of submitting to the medical follow-up of the study for geographical, social reasons or psychiatric illness.
  • Patients admitted to a health or social establishment for purposes other than that of the study

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CHU Jean Minjoz

    Besançon

  • Centre Hospitalier Boulogne/ Mer

    Boulogne-sur-Mer

  • Hôptial Henri Mondor

    Créteil

  • Chu Dijon

    Dijon

  • Hôpital Privé Jean Mermoz

    Lyon

  • GH Pitié Salpêtrière

    Paris

  • Hôpital Saint Antoine

    Paris

  • CHU Poitiers

    Poitiers

  • Hôpital Robert Debré

    Reims

  • CHU Pontchaillou

    Rennes

  • CHU Tours Hôpital Trousseau

    Tours

Other trials in France

About this study

Official title: A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine

The purpose of this study is to assess the incidence of cardiovascular events in patients with esophageal/stomach or colorectal cancer treated by trifluridine/tipiracil +/- oxaliplatin after an episode of cardiac angina-related thoracic pain due to fluoropyrimidines in the adjuvant or metastatic setting .

Read the detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 14-day screening period to determine eligibility for study entry. Patient who meet the eligibility requirement will be included in the study and will be treated by trifluridine/tipiracil +/- oxaliplatin.

Being tested
Trifluridine/Tipiracil, Oxaliplatin
Keywords
cardiac toxicity
Medical subject headings
Cardiotoxicity

What participants receive

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

  • Trifluridine/TipiracilDrug

    Also called Lonsurf

    Trifluridine/tipiracil : 35 mg/m² orally twice a day from day 1 to day 5 every 14 days.

    If oxaliplatin is stopped or it is not indicated, trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.

  • OxaliplatinDrug

    Also called Eloxatin

    Oxaliplatin : 85 mg/m² intravenous at day 1 every 14 days.

Study groups in NCT04894123
Study groupRoleWhat they receive
trifluridine/tipiracil +/- oxaliplatinExperimentalTrifluridine/tipiracil 35 mg/m² orally twice a day from day 1 to day 5 plus oxaliplatin 85 mg/m² intravenous at day 1 every 14 days. If oxaliplatin is stopped for neurotoxicity, allergic reaction or other reason, or it is not indicated, patients will continue trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.
Receives: Drug: Trifluridine/Tipiracil; Drug: Oxaliplatin

What is being measured

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

  1. Rate of cardiovascular events at 3 months.

    Assessment of the rate of cardiovascular events in patients treated by trifluridine/tipiracil +/- oxaliplatin over a 3-month period.

    Measured: At 3 months

Secondary outcomes (3)

  1. Number of patients with treatment-related adverse events by CTCAE 5.0

    Safety profile of the trifluridine/tipiracil and oxaliplatin combination

    Measured: Assessed up to 48 months

  2. Number of patients with disease control rate (DCR)

    DCR defined as partial response, complete response (CR), or stable disease (SD).

    Measured: Assessed up to 48 months

  3. The 3-month drop-out rate of limiting toxicity

    Drop-out rate defined as the number of patients who left the study due to limiting toxicity between treatment initiation and 3 months.

    Measured: At 3 months

Timeline

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

  1. First posted20 May 2021
  2. Study start7 Feb 2022
  3. Primary completion13 Feb 2023
  4. Study completion13 Feb 2023

Why it stopped: Recruitment failure

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894123
Sponsor's protocol ID
ACOTAS G-098
Status last verified
Sep 2023
First submitted
16 May 2021
Last updated
18 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trifluridine/Tipiracil and Oxaliplatin in people with Colorectal Adenocarcinoma and Oesogastric, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 11 sites in France.

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 23 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. 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: Recruitment failure). 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?

Rate of cardiovascular events at 3 months. (time frame: At 3 months). 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 NCT04894123.

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 Sep 2023.

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