NCT01249352

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 31, 2025

Status Verified

January 1, 2014

Enrollment Period

4.8 years

First QC Date

November 25, 2010

Last Update Submit

March 26, 2025

Conditions

Esophageal CancerAdenocarcinoma

Keywords

Esophageal CancerNimotuzumabEF024EF024-201

Outcome Measures

Primary Outcomes (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.

    2 years

Secondary Outcomes (1)

  • Complete clinical response rate

    2 years

Study Arms (2)

STANDARD CHEMORADIATION

ACTIVE COMPARATOR

Cisplatin 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.

Drug: NimotuzumabDrug: CisplatinDrug: FluorouracilRadiation: Radiotherapy

CHEMORADIATION + NIMOTUZUMAB

EXPERIMENTAL

Nimotuzumab 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.

Drug: NimotuzumabDrug: CisplatinDrug: FluorouracilRadiation: Radiotherapy

Interventions

NimotuzumabDRUG

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

CHEMORADIATION + NIMOTUZUMABSTANDARD CHEMORADIATION
CisplatinDRUG

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

CHEMORADIATION + NIMOTUZUMABSTANDARD CHEMORADIATION
FluorouracilDRUG

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

CHEMORADIATION + NIMOTUZUMABSTANDARD CHEMORADIATION
RadiotherapyRADIATION

Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day

CHEMORADIATION + NIMOTUZUMABSTANDARD CHEMORADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • 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;
  • +1 more criteria

You may not qualify if:

  • 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;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hospital Evangélico do Cachoeiro do Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Location

Hospital Universitário de Brasília

Brasília, Federal District, Brazil

Location

Santa Casa de Misericórdia de BH

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Erasto Gaetner

Curitiba, Paraná, Brazil

Location

Hospital Geral de Bonsucesso

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Instituto Nacional do Câncer (INCA)

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital da cidade de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro de Novos Tratamentos de Itajaí

Itajaí, Santa Catarina, Brazil

Location

Hospital Municipal São José

Joinville, Santa Catarina, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Location

Centro Oncológico Mogi das Cruzes

Mogi das Cruzes, São Paulo, Brazil

Location

Faculdade de Medicina do ABC / CEPHO

Santo André, São Paulo, Brazil

Location

Centro de Estudos de Investigações Clíncas (CEIC)

São Caetano do Sul, São Paulo, Brazil

Location

Hospital de Base

São José do Rio Preto, São Paulo, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Location

Hospital São Paulo (UNIFESP)

São Paulo, São Paulo, Brazil

Location

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 29179134DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsAdenocarcinoma

Interventions

nimotuzumabCisplatinFluorouracilRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2010

First Posted

November 29, 2010

Study Start

January 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 31, 2025

Record last verified: 2014-01

Locations

BR(19)