esophageal cancer
Conditions
Interventions
A: Receiving cisplatin (80 mg/m2, 2-h intravenous infusion on day 1) and fluorouracil (800 mg/m2, 24-h continuous intravenous infusion on days 1-5), repeated every 4 weeks
B: Receiving docetaxel (30 m
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction 2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma (Siewert type II/III adenosquamous carcinoma or adenocarcinoma is ineligible.) 3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy A)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases ii)cT1-cT4a iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through B)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases ii)Dysphagia score =<2 4)Aged 20 to 75 years old 5)ECOG PS of 0 or 1 6)No symptomatic bone or brain metastases 7) No massive ascites/pleural effusion 8)Measurable lesions not required 9)As for previous therapy, either A) or B) must be fulfilled: A)When preoperative chemotherapy or postoperative chemotherapy was given as previous therapy, meet all of the following 4 factors: i)Recurrence was detected more than 24 weeks after previous therapy was completed ii)Previous therapy was not terminated due to adverse events, patient refusal iii)Tumor response by previous therapy was not judged as disease progression iv)Total dose of prior CDDP =< 210 mg/m2 B)When preoperative chemoradiotherapy, concurrent chemoradiotherapy or radiotherapy alone were received as previous therapy, meet all of the following 5 factors: i)More than 52 weeks after radiotherapy when lung was involved in radiation field ii)No history of grade 2-4 pneumonitis iii)Previous therapy was not terminated due to adverse events, patient refusal iv)Tumor response by previous therapy was not judged as disease progression v)Total dose of prior CDDP =< 210 mg/m2 10)Sufficient organ function 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Pregnancy, possible pregnancy or breastfeeding. 4) Psychiatric disease. 5) Patients requiring systemic steroid medication. 6) Under treatment with flucytosine, phenytoin, or warfarin. 7) History of iodine allergy. 8) History of hypersensitivity to DOC, CDDP, or polysorbate 80. 9) Poorly controlled diabetes mellitus. 10) Severe pulmonary fibrosis or emphysema. 11) Poorly controlled hypertension. 12) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months. 13) Positive HBs antigen, or positive HIV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, response rate, proportion of adverse events | — |
Countries
Japan
Contacts
Public ContactShuichi Hironaka
JCOG1314 Coordinating Office Clinical Trial Promotion Department, Chiba Cancer Center
Outcome results
None listed