Unresectable esophageal squamous cell carcinoma after induction chemotherapy
Conditions
Interventions
Docetaxel
Sponsors
Gastroenterologic surgery, Kanazawa university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20-75 years of age. 2) Thoracic esophageal squamous cell carcinoma. 3) Unresectable state (T4 or N4) after induction chemotherapy. 4) With or without multiple lesions or intramucosal extension. 5) Without the tumor extension to cervical esophagus or gastric cardia. 6) Without distant metastasis. 7) No prior treatment except planned induction chemotherapy for esophageal cancer. 8) With a performance status of 0 or 1. 9) No major organ function abnormality. Laboratory measurements required at study registration include the followings: white blood cells, >3000/mm3; hemoglobin, >9.0 g/dL; GOT and GPT, <100 IU; total bilirubin, >2.0 mg/dL; arterial oxygen pressure, >60 Torr; serum creatinine, >1.2 mg/dL and creatinine clearance, >60 ml/mn. 10) Written informed consent is obtained before registration.
Exclusion criteria
Exclusion criteria: 1) The presence of esophageal fistula 2) The presence of severe combined diseases including hear failure, renal failure, hepatic failure and uncontrollable diabetes mellitus. 3) Active infectious diseases (exept HBV or HCV infection). 4) Previous radiotherapy to chest. 5) Apparent interstitial pneumonia or lung fibrosis. 6) Combined active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 7) The presence of motor paralysis, peripheral neuropathy or edema. 8) No usage of contraceptive method for patients with reproductive age. 9) The presence of mental disease or disorder with difficulty in participating in the clinical trial. 10) Inadequate for clinical trial entry by the attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: To determine the maximaum tolerated dose (MTD) and recommended dose (RD) of Docetaxel Phase II: 2 year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: response rate Phase II: complete remission rate, progression free survival, the rate of occurrence of adverse event, the rate of occurrence of late adverse event | — |
Countries
Japan
Contacts
Public ContactItasu Ninomiya
Kanazawa university Gastroenterologic surgery
Outcome results
None listed