Esophageal cancer
Conditions
Interventions
bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS)
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Primary tumor located cervical esophagus (Ce) or thoracic esophagus (Te) according to the 7th UICC-TNM classification 2)Histologically confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma 3)Unresectable advanced or recurrent tumor with no indication for definitive treatment (surgery, radiotherapy, and chemoradiotherapy) 4)Age over 20 years old. 5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 6)Without symptomatic bone or brain metastases 7)Without massive pleural effusion (more than half of one side thoracic cavity) nor massive ascites (more than from pelvic cavity to upper abdomen) 8)With evaluable lesions according to RECIST ver 1.1 (measurable lesions not required) 9)As for previous therapy for esophageal cancer, 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: a.Recurrence was detected more than 24 weeks after previous therapy was completed b.Previous therapy was not terminated due to adverse events, patient refusal c.Tumor response by previous therapy was not judged as disease progression d.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: a.More than 52 weeks after radiotherapy when lung was involved in radiation field b.No history of grade 2-4 pneumonitis c.Previous therapy was not terminated due to adverse events, patient refusal d.Tumor response by previous therapy was not judged as disease progression e.Total dose of prior CDDP =<210 mg/m2 10)Adequate organ functions: 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy 2)With active systemic infection disease 3)With active hepatitis B or C 4)With HIV infection 5)With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 6)Severe psychological illness. 7)With continuous systemic steroid or immune-suppressive drug therapy. 8)Poorly controlled diabetes mellitus or thyroid diseases. 9)Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months 10)With history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations 11)Pregnant and/or nursing women or men who wish to have children in future 12)Judged to be unfit to participate in this study by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PhaseI part: DLT PhaseII part:PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| PhaseI part: Adverse Event PhaseII part: Overall survival(OS), Response rate(RR), Adverse Event, Quality of life(QOL) | — |
Countries
Japan
Contacts
Public ContactYasuyoshi Sato
The University of Tokyo Department of Gastrointestinal Surgery
Outcome results
None listed