Status:
COMPLETED
A Study of Chemoradiation Associated with Nimotuzumab As the Treatment of Locally Advanced Esophageal Cancer
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Esophageal Cancer
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
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 nimotuz...
Eligibility Criteria
Inclusion
- 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;
- He/she must have signed the informed consent form
Exclusion
- 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).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01249352
Start Date
January 1 2009
End Date
November 1 2013
Last Update
March 31 2025
Active Locations (19)
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1
Hospital Evangélico do Cachoeiro do Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, Brazil
2
Hospital Universitário de Brasília
Brasília, Federal District, Brazil
3
Santa Casa de Misericórdia de BH
Belo Horizonte, Minas Gerais, Brazil
4
Hospital Erasto Gaetner
Curitiba, Paraná, Brazil