AzTrials
AzTrials

Esophageal CancerPhase 3NCT05547529

The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer

A Phase 3 study testing Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy. and Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy in people with Esophageal Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the safety, feasibility and outcomes of neoadjuvant chemotherapy followed by esophagectomy versus neoadjuvant chemoradiotherapy followed by esophagectomy for locally advanced resectable esophageal squamous cell carcinoma cT3-4aN0M0, cT1-4aN1-3M0. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Esophageal Cancer
What is being tested?
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy. and Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteRussia
Study dates
14 Sep 2022to 14 Sep 2027
Phase
Phase 3
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Histologically confirmed squamous cell carcinoma of the esophagus.
  • Clinical stage cT1-4aN1-3M0 (AJCC/UICC 8th Edition).
  • Indications for surgical esophageal resection
  • ECOG status 0-1.
  • Adequate bone marrow function (White Blood Cells > 3.0 x 109/L; Neutrophil > 2.0 × 109/L; Hemoglobin > 90 g/L; Platelets > 100 x 109/L).
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  • Adequate liver function (Total bilirubin < 1.5 x Upper Level of Normal (ULN); Aspartate transaminase (AST) and Alanine transaminase (ALT) < 3.0 x ULN);
  • Adequate renal function (Glomerular filtration rate (CCr) > 50 ml/min.
  • Adequate cardiac function. Left ventricular ejection fraction > 50%.
  • Age from 18 years to 70

Who cannot join

  • Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition).
  • Patients with advanced non-operable or metastatic esophageal cancer.
  • Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy.
  • Patients with another previous or current malignant disease.
  • Allergy or contraindications to Paclitaxel, Carboplatin, Docetaxel, Cisplatin or Fluoruracil.
  • Patients with active infection of immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); HIV seropositivity; HBV DNA or HCV RNA positive.
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  • Severe concomitant diseases (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors, etc.).
  • Clinically significant coronary artery disease (NYHA III / IV), congestive heart failure (NYHAIII / IV), clinically significant cardiomyopathy, myocardial infarction within the last 6 months, or high risk of uncontrolled arrhythmia.
  • Chronic inflammatory diseases of the gastrointestinal tract
  • Acute infectious diseases.
  • Pregnancy or breast feeding.
  • Serious concomitant physical and mental illness / abnormalities or territorial reasons that may prevent the patient from participating in the protocol and adherence to the protocol schedule.
  • Foreigners or persons with limited legal rights.
  • Any medical, geographic, or social circumstance, that in the opinion of the investigator excludes the patient's participation in the protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Omar Abouhaidar, MD, PhD contact

+79269125902

abouhaidar@yandex.ru

Parvin Akhmedov contact

+79267333323

Akhmedovparvin@gmail.com

Russia1 site, 1 recruiting

  • N.N. Blokhin National Medical Research Center of Oncology

    Moscow, 115478

    Pavel Kononets

    Pavel Kononets

    Recruiting

Other trials in Russia

About this study

Official title: An Open-Label Randomized Clinical Trial to Evaluate the Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer cT3-4aN0M0, cT1-4aN1-3M0.

The purpose of this study is to evaluate the safety, feasibility and outcomes of neoadjuvant chemotherapy followed by esophagectomy versus neoadjuvant chemoradiotherapy followed by esophagectomy for locally advanced resectable esophageal squamous cell carcinoma cT3-4aN0M0, cT1-4aN1-3M0. This is non-inferiority study (neoadjuvant chemoradiotherapy has no advantage over neoadjuvant chemotherapy).

Read the detailed description

It is a prospective open-label randomized phase III clinical trial sponsored by N.N. Blokhin NMRC of Oncology. 156 patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0M0, cT1-4aN1-3M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (nCRT) followed by esophagectomy and the neoadjuvant chemotherapy group (nCT) followed by esophagectomy according to the proportion of 1:1. The safety, efficacy of protocols and prognosis of patients are compared between the two regimens.

Being tested
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy., Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.Procedure or surgery

    Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.

  • Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomyProcedure or surgery

    Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

Study groups in NCT05547529
Study groupRoleWhat they receive
Neoadjuvant ChemoradiotherapyActive comparatorCarboplatin (AUC 2 mg/mL per min) and Paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. A total radiation dose of 41,4 Gy was given in 23 fractions of 1,8 Gy, 5 days per week. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.
Receives: Procedure: Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Neoadjuvant ChemotherapyExperimental4 cycles of DCF regimen (docetaxel 75 mg/m2 day, CDDP 75 mg/m2 and 5FU at 750 mg/m2/ day for 5 days) every 3 weeks. Patients with dysphagia 3 оr with weight loss more then 10% 6 cycles of modified-DCF regimen will be performed (mDCF, docetaxel 50 mg/m2 day, CDDP 50 mg/m2 day and 5-FU at 2400 mg/m2/day for 2 days) every 3 weeks. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.
Receives: Procedure: Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

What is being measured

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

  1. Disease-free survival

    Survival without local or systemic recurrence

    Measured: 3(5) years after last patient enrolled

Secondary outcomes (6)

  1. Overall survival

    Overall survival of patients

    Measured: 3(5) years after last patient enrolled

  2. Treatment related complications

    Сomplications after treatment

    Measured: During the procedure

  3. Number of cycles, frequency of neoadjuvant therapy reduction

    Number of chemotherapy/chemoradiotherapy cycles and doses and dose reductions

    Measured: During the procedure

  4. Correlation between genetic profile and tumor response

    Influence of the genetic profile on the tumor response

    Measured: Immediately after the procedure

  5. Pathological response rate(pCR)

    Frequency of pathological pathomorphosis

    Measured: Immediately after the surgery

  6. R0 resection rate

    Residual tumor rate

    Measured: Immediately after the surgery

Timeline

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

  1. First posted21 Sep 2022
  2. Study start14 Sep 2022
  3. Primary completion14 Sep 2025 (estimated)
  4. Study completion14 Sep 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05547529
Sponsor's protocol ID
ENCHENEC
Status last verified
Sep 2022
First submitted
14 Sep 2022
Last updated
4 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We are not planning to share personal patient data

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy. and Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy in people with Esophageal Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.

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 10 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: looking for participants now, as of the sponsor's last update on 4 Oct 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 Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Omar Abouhaidar, MD, PhD (+79269125902, abouhaidar@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 3(5) years after last patient enrolled). 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 NCT05547529.

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 4 Oct 2022.

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