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

NCT ID: NCT01249352

Last Updated: 2025-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-11-30

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.

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.

Conditions

Esophageal Cancer; Adenocarcinoma

Keywords

Esophageal Cancer; Nimotuzumab; EF024; EF024-201

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STANDARD CHEMORADIATION

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.

Group Type: ACTIVE_COMPARATOR

Nimotuzumab

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Fluorouracil

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day

CHEMORADIATION + NIMOTUZUMAB

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.

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Fluorouracil

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day

Interventions

Nimotuzumab

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Fluorouracil

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

Intervention Type: DRUG

Radiotherapy

Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years;

2. Histological prove of SCC or esophageal adenocarcinoma;

3. T1N1M0, T2N1M0, T3N0M0, T4N0M0, T3N1M0, T4N1M0, qqTqqNM1a stage, according to the TNM system42;

4. Life expectation above 6 months;

5. 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);

6. Performance status 0, 1, or 2, according to the Eastern Cooperative Oncology Group criteria44 (ECOG) (see Appendix C);

7. Creatinine clearance ≥ 60 ml/min, according to the Cockcroft and Gault formula45 (see Appendix D);

8. 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;

9. Adequate calorie ingestion, at the investigator's discretion;

10. He/she must have signed the informed consent form

Exclusion Criteria

1. Previous or planned treatment of esophageal carcinoma with surgery, radiotherapy, chemotherapy, or antineoplastic biological therapy;

2. Presence of active infection;

3. Knowledge of the presence of HIV seropositivity;

4. 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;

5. Presence of a significant neurological or psychiatric disease, including dementia and seizures, as per the investigator's judgment;

6. History of malignant neoplasm, except for adequately treated skin basal carcinoma or SCC, and cervical carcinoma in situ;

7. Presence of peripheral neuropathy;

8. Knowledge of the presence of hypersensitivity or allergy to drugs that will be administered in this protocol;

9. History of severe allergic reaction;

10. Pregnancy or lactation;

11. Presence of aerodigestive fistula (trachea and/or bronchia);

12. Evident presence of trachea and/or bronchia infiltration by the tumor;

13. Presence of uncontrolled hypercalcaemia ≥ 2.9 mmol/L (or grade >1, according to the NCI-CTCAE, version 3.0).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Evangélico do Cachoeiro do Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Hospital Universitário de Brasília

Brasília, Federal District, Brazil

Santa Casa de Misericórdia de BH

Belo Horizonte, Minas Gerais, Brazil

Hospital Erasto Gaetner

Curitiba, Paraná, Brazil

Hospital Geral de Bonsucesso

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto Nacional do Câncer (INCA)

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital da cidade de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Novos Tratamentos de Itajaí

Itajaí, Santa Catarina, Brazil

Hospital Municipal São José

Joinville, Santa Catarina, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Centro Oncológico Mogi das Cruzes

Mogi das Cruzes, São Paulo, Brazil

Faculdade de Medicina do ABC / CEPHO

Santo André, São Paulo, Brazil

Centro de Estudos de Investigações Clíncas (CEIC)

São Caetano do Sul, São Paulo, Brazil

Hospital de Base

São José do Rio Preto, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Hospital São Paulo (UNIFESP)

São Paulo, São Paulo, Brazil

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 29179134 (View on PubMed)

Other Identifiers

EF024-201

Identifier Type: -

Identifier Source: org_study_id