JPRN-jRCTs051180082
Recruiting
Phase 1
Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU for clinical stage IA-IIIC esophageal cancer.(PCF-RT) - Phase I study of PCF-RT
Yamamoto Sachiko0 sites24 target enrollmentFebruary 28, 2019
ConditionsEsophageal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Esophageal cancer
- Sponsor
- Yamamoto Sachiko
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically proven squamous cell carcinoma, or adenosquamous cell carcinoma or basaloid of the esophagus
- •2\) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
- •3\) Aged 20 to 75 years old
- •4\) ECOG PS of 0 or 1
- •5\) Clinical stage IA \- IIIC
- •6\) No need for measurable lesion
- •7\) No previous treatment of esophageal cancer except endoscopic surgery
- •8\) No palsy of recurrent nerve
- •9\) No adaptation of surgery or refused esophagectomy
- •10\) Adequate organ functions
Exclusion Criteria
- •1\) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer or expected cure in surgery
- •2\) history of radiotherapy for mediastinum
- •3\) Uncontrollable diabetes mellitus
- •4\) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac function disorder
- •5\) Uncontrollable arrhythmia
- •6\) Patients requiring systemic steroids medication
- •7\) Liver cirrhosis
- •8\) Active bacterial or fungous infection
- •9\) With a history of grade 2\-4 allergic reaction by CTCAE version 4\.0
- •10\) With a history of grade 2\-4 nerve disturbance by CTCAE version 4\.0
Outcomes
Primary Outcomes
Not specified
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