Clinical trial NCT01249352 (phase 2/phase 3, status: completed)
Conditions: esophageal cancer, adenocarcinoma
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: nimotuzumab, cisplatin, fluorouracil
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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).