elderly PTX-RT
- Conditions
- Esophageal Cancer
- Registration Number
- JPRN-jRCTs031180283
- Lead Sponsor
- Hamamoto Yasuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 74
1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma.
2) Primary tumor located in thoracic esophagus. Second tumors in cervical or abdominal esophagus which is indicated for EMR/ESD are also eligible.
3) Clinical stages IB, II or III based on the 7th UICC-TNM classification.
4) Patients who are amenable to 60Gy radiation therapy.
5) >=70 years old.
6)
i) >=70 and <80 year-old-patient, PS (ECOG) of 0 or 1, and Creatinine>=1.5mg/dl.
ii) >=70 and <80 year-old-patient, PS (ECOG) of 2.
iii) >=80 year-old-patient, PS (ECOG) of 0 and 1.
7) Patients have measurable and/or non-measurable disease according to RECIST ver1.1.
8) No prior treatment against esophageal cancer except for endoscopic resection.
9) No prior chemotherapy and radiation therapy.
10) Sufficient organ functions.
i) Neutrophil >= 1500/mm3
ii) WBC < 12000/mm3
iii) Platelet >= 100000/mm3
iv) T.Bil =< 1.5mg/dL
v) AST =< 100IU/L
vi) ALT =< 100IU/L
11) Refused esophagectomy.
12) Written informed consent.
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Infectious disease with systemic therapy indicated.
3) Severe psychiatric disease.
4) Continuous systemic steroid therapy.
5) Poorly controlled diabetes mellitus.
6) Severe pulmonary fibrosis or emphysema.
7) Unstable angina pectoris, or history of myocardial infarction within three months.
8) Other conditions not suitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Phase I> <br>The frequency of DLT (Dose Limiting Toxicity) <br><Phase II> <br>Two year survival rate
- Secondary Outcome Measures
Name Time Method <Phase I> <br>Adverse event, Overall survival, Progression-free survival, Complete response rate, Pharmacokinetics, Geriatric Assessment <br><Phase II> <br>Complete response rate, Progression-free survival, Adverse event, Late toxicity, Geriatric Assessment