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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1041180004
Enrollment
21
Registered
2018-09-11
Start date
2018-09-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Chemoradiation Cisplatin 75 mg / m2 day 1 Fluorouracil 1000 mg / m2 / day days 1 - 4 (96 hours), 2 courses every 4 weeks Radiotherapy 1.8 Gy / fr x 23 fr Total 41.4 Gy

Sponsors

Maeda Osamu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Rate of adveser events, response rate, rate of complete resection, histopathological response rate, histopathological complete response rate, rate of perioperative complication, rate of late complication, rate of severe adverse events, progression-free survival, and overall survival

Contacts

Public ContactOsamu Maeda

Nagoya University

maeda-o@med.nagoya-u.ac.jp+81-52-744-1903

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026