JPRN-jRCT2091220010
Completed
Phase 1
Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604) - JCOG0604
Japan Clinical Oncology Group(JCOG)0 sites81 target enrollmentMay 11, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Japan Clinical Oncology Group(JCOG)
- Enrollment
- 81
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma of the esophagus
- •2\) Primary lesion are located within the thoracic esophagus (Te)
- •3\) Clinical stage II or III without T4
- •4\) Aged 20 to 70 years old
- •5\) ECOG PS of 0 or 1
- •6\) no need for measurable lesion
- •7\) no previous treatment of esophageal cancer
- •8\) no previous chemotherapy or radiotherapy against any other malignancies
- •9\) adequate water intake
- •10\) no palsy of recurrent nerve
Exclusion Criteria
- •1\) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
- •2\) Patients requiring the administration of phenytoin or warfarin potassium
- •3\) Pregnant or lactating women or women of childbearing potential
- •4\) Psychosis
- •5\) Patients requiring systemic steroids medication
- •6\) HBs antigen positive
- •7\) Uncontrollable diabetes millutus or requiring administration of insulin
- •8\) Uncontrollable hypertension
- •9\) History of myocardial infarction or unstable angina pectoris
- •10\) Interstitial pneumonia, fibroid lung or severe emphysema
Outcomes
Primary Outcomes
Not specified
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