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Phase II study of neoadjuvant chemoradiation therapy with cisplatin plus fluorouracil for esophageal cancer

Phase 2
Conditions
Esophageal cancer
Registration Number
JPRN-jRCT1041180004
Lead Sponsor
Maeda Osamu
Brief Summary

Twelve patients received chemoradiotherapy and 11 underwent esophagectomy. Side effects were manageable.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
12
Inclusion Criteria

1.ECOG PS 0-1
2.Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma or basal cell carcinoma.
3. Any of the following based on TNM classification (UICC-TNM 7 th edition)
1) cStage IB
2) cStage II
3) cStage III Infiltration into the trachea at the cervical /cervical chest boundary (T4) is eligible. Excluding other T4. So-called borderline-resectable T4 disease, not clearly diagnosed as T4, is eligible.
4) cStage IV with supraclavicular lymph node metastasis and without other distant metastasis.
4. Adequate organ function.

Exclusion Criteria

1) Clear T4 other than invasion of cervical / cervical gastrointestinal tract esophageal cancer
2) Distant metastasis to other than supraclavicular lymph nodes.
3) Esophagogastric junction lesion of which main lesion is located in the stomach rather than the esophagus.
4) Judged not to be eligible by the researchers

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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