Clinical trial NCT00047112 (phase 3, status: completed)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: 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:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of stage I or II thoracic esophageal cancer

               -  Tumor no greater than 3 cm with no invasion of mediastinal structures with or
                  without extension to the lymph nodes (T1-2, N0-1, M0) OR

               -  Tumor greater than 3 cm with no invasion of mediastinal structures and no
                  adenopathy greater than 1 cm (T3, N0, M0)

               -  Epidermoid carcinoma or adenocarcinoma

          -  Previously untreated

          -  Deemed resectable with curative intent

          -  No carcinoma in situ

          -  No small cell anaplastic carcinoma (i.e., chromogranin negative)

          -  No small cell neuroendocrine carcinoma (i.e., chromogranin positive)

          -  No multifocal esophageal carcinoma (i.e., 2 or more distinct lesions 5 or more cm
             apart)

          -  No involvement of the pharyngoesophageal junction and the first 4 cm of the esophagus
             (i.e., where the proximal edge of the tumor is less than 19 cm from the dental arch)

          -  No evidence of extension to the tracheobronchial tree at endoscopy, ultrasound, or CT
             scan (simple compression allowed)

          -  No signs of mediastinal involvement on CT scan

          -  No palpable subclavicular lymph nodes or involvement after cytology needle aspiration

          -  No lymph nodes from the origin of the celiac greater than 1 cm on CT scan

               -  Perigastric lymph nodes far from the celiac trunk and deemed resectable allowed
                  unless tumor is more than 30 mm on CT scan

        PATIENT CHARACTERISTICS:

        Age

          -  Under 75

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  SGOT/SGPT ratio no greater than 1

          -  Albumin at least 35 g/L

          -  Total protein greater than 80%

          -  No liver cirrhosis with previous failure

          -  No ascites

          -  No jaundice

          -  No rupture of varicose esophageal veins

          -  No presence of varicose esophageal veins

        Renal

          -  Creatinine no greater than 1.25 times normal

        Cardiovascular

          -  Arterial O_2 greater than 60 mm Hg

          -  Arterial CO_2 no greater than 45 mm Hg

          -  No myocardial infarction within the past 6 months

          -  No progressive coronary artery disease grade 2 or greater

          -  No recent left ventricular failure

          -  No arterial disease stage II-IV

        Pulmonary

          -  FEV_1 greater than 1 L/sec

        Other

          -  Able to receive either study treatment

          -  No recurrent paralysis

          -  No weight loss greater than 10% from baseline

          -  No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
             situ of the cervix

          -  Not pregnant

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of chemotherapy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified