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Esophageal Squamous Cell CarcinomaPhase 2NCT04699994

Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel

A Phase 2 study testing FLOT therapy in people with Esophageal Squamous Cell Carcinoma, run by Keio University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
FLOT therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteJapan
Study dates
25 Jun 2020to 31 Oct 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid)
  • Primary tumor is located mainly in the thoracic esophagus
  • cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1)
  • Twenty years old or older as of registration
  • Performance status (PS) 0 or 1
  • Patients have target lesions
Show all 16Show fewer
  • No previous history of esophageal cancer except for the followings
  • 1) pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD 8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval 9. Patients who meet the following criteria
  • Neutrophil > 1,500 /mm3
  • Platelet > 10.0x10^4 /mm3
  • Hb ≧9.0 g/dL
  • Total bilirubin ≦ 1.5 mg/dL
  • AST ≦ 100 IU/L
  • ALT ≦ 100 IU/L
  • SpO2 ≧ 95 %
  • Creatinine clearance ≧ 50 mL/min 10. Patients who can undergo esophagectomy 11. Agree with the participation to the current study

Who cannot join

  • Patients who received any treatment for cancer within 3 years
  • Patients who have active infectious diseases
  • HBs Ag positive or HIV Ab positive
  • Pregnant or breast feeding
  • Patients with psychological disorder
  • On systemic steroid therapy
Show all 14Show fewer
  • Require flucytocine, phenytoin, warfarin
  • Allergic to iodine
  • Allergic to DTX, LOHP, polisorbate 80
  • Uncontrollable diabetes
  • Severe COPD or lung fibrosis
  • Severe hypertension
  • Unstable angina
  • Patients whom investigators evaluate as ineligible

Trial locations and contacts

1 site in 1 country.

Satoru Matsuda contact

+81333531211

s.matsuda.a8@keio.jp

Japan1 site, 1 recruiting

  • Keio University Hospital

    Tokyo, 1608582

    Satoru Matsuda, +81333531211, s.matsuda.a8@keio.jp

    Recruiting

Other trials in Japan

About this study

Official title: Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)

The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.

Being tested
FLOT therapy
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • FLOT therapyDrug

    Preoperative FLOT therapy

Study groups in NCT04699994
Study groupRoleWhat they receive
FLOT therapyExperimentalNot described
Receives: Drug: FLOT therapy

What is being measured

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

  1. Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)

    Measured: 2.5 years

Secondary outcomes (11)

  1. Response rate

    Measured: 2.5 years

  2. Histological complete response rate

    Measured: 2.5 years

  3. Treatment completion rate

    Measured: 2.5 years

  4. Curative resection rate

    Measured: 2.5 years

  5. Recurrence free survival

    Measured: 4.5 years

  6. Overall survival

    Measured: 4.5 years

  7. Incidence rate of adverse event during FLOT

    Measured: 2.5 years

  8. Perioperative complication rate

    Measured: 2.5 years

  9. Late phase complication rate

    Measured: 4.5 years

  10. Incidence rate of severe adverse event

    Measured: 2.5 years

  11. Incidence rate of all adverse event

    Measured: 4.5 years

Timeline

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

  1. First posted7 Jan 2021
  2. Study start25 Jun 2020
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04699994
Sponsor's protocol ID
N20190007
Status last verified
Aug 2022
First submitted
5 Jan 2021
Last updated
17 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FLOT therapy in people with Esophageal Squamous Cell Carcinoma, run by Keio University at 1 site in Japan.

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 16 inclusion and 14 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 17 Aug 2022. 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 Japan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Satoru Matsuda (+81333531211, s.matsuda.a8@keio.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition) (time frame: 2.5 years). 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 NCT04699994.

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 17 Aug 2022.

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