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Esophageal CancerPhase 2/3NICENCT01249352

A Study of Chemoradiation Associated with Nimotuzumab As the Treatment of Locally Advanced Esophageal Cancer

A Phase 2/3 study testing Nimotuzumab, Cisplatin and Fluorouracil in people with Esophageal Cancer and Adenocarcinoma, run by Eurofarma Laboratorios S.A. at 19 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to assess the efficacy of nimotuzumab in combination with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer, comparing it to that of the conventional treatment with radiation and chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Adenocarcinoma
What is being tested?
Nimotuzumab, Cisplatin and Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
19 sitesBrazil
Study dates
Jan 2009to Nov 2013
Phase
Phase 2/3
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

  • Age ≥ 18 years;
  • Histological prove of SCC or esophageal adenocarcinoma;
  • T1N1M0, T2N1M0, T3N0M0, T4N0M0, T3N1M0, T4N1M0, qqTqqNM1a stage, according to the TNM system42;
  • Life expectation above 6 months;
  • Inoperable superior, medial, or distal third esophageal cancer, including GE junction tumors, defined as type I and II tumors in the Siewert classification43 (see Appendix B);
  • Performance status 0, 1, or 2, according to the Eastern Cooperative Oncology Group criteria44 (ECOG) (see Appendix C);
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  • Creatinine clearance ≥ 60 ml/min, according to the Cockcroft and Gault formula45 (see Appendix D);
  • Adequate body functions, indicated by
  • Creatinine clearance ≥ 60 ml/min;
  • Bilirubin, transaminase, alkaline phosphatase, and gamma-GT < 1,5 x the upper limit of normal;
  • leucocytes ≥ 3000/μl;
  • granulocytes ≥ 1500/ μl;
  • hemoglobin ≥ 9 g/dl;
  • platelets ≥ 80000/ μl;
  • Adequate calorie ingestion, at the investigator's discretion;
  • He/she must have signed the informed consent form

Who cannot join

  • Previous or planned treatment of esophageal carcinoma with surgery, radiotherapy, chemotherapy, or antineoplastic biological therapy;
  • Presence of active infection;
  • Knowledge of the presence of HIV seropositivity;
  • Presence of severe comorbidities that, in the investigator's opinion, will put the patient at a significantly higher risk or will damage the protocol compliance;
  • Presence of a significant neurological or psychiatric disease, including dementia and seizures, as per the investigator's judgment;
  • History of malignant neoplasm, except for adequately treated skin basal carcinoma or SCC, and cervical carcinoma in situ;
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  • Presence of peripheral neuropathy;
  • Knowledge of the presence of hypersensitivity or allergy to drugs that will be administered in this protocol;
  • History of severe allergic reaction;
  • Pregnancy or lactation;
  • Presence of aerodigestive fistula (trachea and/or bronchia);
  • Evident presence of trachea and/or bronchia infiltration by the tumor;
  • Presence of uncontrolled hypercalcaemia ≥ 2.9 mmol/L (or grade >1, according to the NCI-CTCAE, version 3.0).

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Brazil19 sites

  • Santa Casa de Misericórdia de BH

    Belo Horizonte, Minas Gerais

  • Hospital Universitário de Brasília

    Brasília, Federal District

  • Hospital Evangélico do Cachoeiro do Itapemirim

    Cachoeiro de Itapemirim, Espírito Santo

  • Hospital Erasto Gaetner

    Curitiba, Paraná

  • Centro de Novos Tratamentos de Itajaí

    Itajaí, Santa Catarina

  • Hospital Amaral Carvalho

    Jaú, São Paulo

  • Hospital Municipal São José

    Joinville, Santa Catarina

  • Centro Oncológico Mogi das Cruzes

    Mogi das Cruzes, São Paulo

  • Hospital da cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul

  • Hospital Geral de Bonsucesso

    Rio de Janeiro, Rio de Janeiro

  • Instituto Nacional do Câncer (INCA)

    Rio de Janeiro, Rio de Janeiro

  • Faculdade de Medicina do ABC / CEPHO

    Santo André, São Paulo

  • Centro de Estudos de Investigações Clíncas (CEIC)

    São Caetano do Sul, São Paulo

  • Hospital de Base

    São José do Rio Preto, São Paulo

  • Hospital Santa Marcelina

    São Paulo, São Paulo

  • Hospital São Paulo (UNIFESP)

    São Paulo, São Paulo

  • Instituto do Câncer do Estado de São Paulo

    São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: A Phase II, Randomized, Controlled, Open-Label Study Comparing Standard Chemoradiation Versus Chemoradiation Associated with Nimotuzumab As the Treatment of Locally Advanced Esophageal Cancer

The primary objective of this study is to assess the efficacy of nimotuzumab in combination with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer, comparing it to that of the conventional treatment with radiation and chemotherapy.

The secondary objective of this study is to assess the health-related quality of life for the nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal cancer.

Read the detailed description

This will be a phase II, randomized, controlled, open-label, multicenter, and two-arm study. The study will be conducted in Brazil and has the purpose of determining the activity and safety of nimotuzumab in terms of overall survival, TTP, clinical and endoscopic response rates, resectability rate, toxicity profile, and quality of life. All participating patients will sign a consent form before they undergo any study-related procedure. The eligible patients will have locally advanced esophageal cancer, and they will be randomized to one of two treatment groups. Randomization will be centrally coordinated by the sponsor and performed by means of the electronic CRF itself.

Being tested
Nimotuzumab, Cisplatin, Fluorouracil, Radiotherapy
Keywords
Esophageal Cancer, Nimotuzumab, EF024, EF024-201
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma

What participants receive

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

  • NimotuzumabDrug

    200 mg, IV Weekly IV dose for up to 26 weeks.

  • CisplatinDrug

    75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab.

  • FluorouracilDrug

    1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles.

  • RadiotherapyRadiation

    Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day

Study groups in NCT01249352
Study groupRoleWhat they receive
STANDARD CHEMORADIATIONActive comparatorCisplatin 75 mg/m2, IV IV doses on D1 of each chemotherapy cycle, for 4 cycles Fluorouracil 1000 mg/m2, IV IV doses in a 24-hour continuous infusion, from D1 to D4 of each chemotherapy cycle, for 4 cycles. Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day Equivalent to 28 fractions for 5 and a half weeks.
Receives: Drug: Nimotuzumab; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiotherapy
CHEMORADIATION + NIMOTUZUMABExperimentalNimotuzumab 200 mg, IV weekly IV doses for up to 26 weeks. Cisplatin 75 mg/m2, IV IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab. Fluorouracil 1000 mg/m2, IV IV dose in a 24-hour continuous infusion, from D1 to D4 of each chemotherapy cycle, for 4 cycles. Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day Equivalent to 28 fractions for 5 and a half weeks.
Receives: Drug: Nimotuzumab; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiotherapy

What is being measured

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

  1. Overall survival and assessment of the complete endoscopic response

    The primary endpoint of this study is the overall survival at the end of Phase II. At the end of Phase II, the assessment of the complete endoscopic response, and the regimen safety will be used to decide if the study will continue to Phase III.

    Measured: 2 years

Secondary outcomes (1)

  1. Complete clinical response rate

    • Time to tumor progression (TTP);
    • Complete clinical response rate, defined as the proportion of patients with absence of visible disease in the high endoscopy and in the chest and abdomen computerized tomography, in the population assessable for response;
    • Complete endoscopic response rate, defined as the absence of visible disease in the high endoscopy;
    • Resectability rate;
    • Safety:
    • Quality of life, according to the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire;
    • Relationship between efficacy and safety and the tumor characteristics.

    Measured: 2 years

Timeline

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

  1. First posted29 Nov 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionNov 2013
  4. Study completionNov 2013

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01249352
Sponsor's protocol ID
EF024-201
Acronym
NICE
Status last verified
Jan 2014
First submitted
25 Nov 2010
Last updated
31 Mar 2025
Results posted
No
Data monitoring committee
No

Publications

  • de Castro Junior G, Segalla JG, de Azevedo SJ, Andrade CJ, Grabarz D, de Araujo Lima Franca B, Del Giglio A, Lazaretti NS, Alvares MN, Pedrini JL, Kussumoto C, de Matos Neto JN, Forones NM, Fernandes Junior HJ, Borges G, Girotto G, da Silva IDCG, Maluf-Filho F, Skare NG. A randomised phase II study of chemoradiotherapy with or without nimotuzumab in locally advanced oesophageal cancer: NICE trial. Eur J Cancer. 2018 Jan;88:21-30. doi: 10.1016/j.ejca.2017.10.005. Epub 2017 Nov 24.

    PubMed 29179134

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nimotuzumab, Cisplatin and Fluorouracil in people with Esophageal Cancer and Adenocarcinoma, run by Eurofarma Laboratorios S.A. at 19 sites in Brazil.

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 13 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 31 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 19 sites in Brazil. 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 combined 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.

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?

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?

Overall survival and assessment of the complete endoscopic response (time frame: 2 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 NCT01249352, 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 31 Mar 2025.

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