Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer

Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer - Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014927

Enrollment

Registered

2014-08-22

Start date

2014-08-22

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

Current chemoradiotherapy with PTX, CDDP, and 5-FU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) Clinical stage I or II or III or IV (with supraclavicular LN) 4) Total radiation dose is 50.4Gy 5) Aged 20 to 75 years old 6) ECOG PS of 0 or1 7) no need for measurable lesion 8) no previous treatment of esophageal cancer except EMR or ESD 9) no previous chemotherapy or radiotherapy against any other malignancies 10) adequate organ functions 11) refused esophagectomy 12) written informed consent

Exclusion criteria

Exclusion criteria: 1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) Clinical stage I or II or III or IV (with supraclavicular LN) 4) Total radiation dose is 50.4Gy 5) Aged 20 to 75 years old 6) ECOG PS of 0 or1 7) no need for measurable lesion 8) no previous treatment of esophageal cancer except EMR or ESD 9) no previous chemotherapy or radiotherapy against any other malignancies 10) adequate organ functions 11) refused esophagectomy 12) written informed consent

Design outcomes

Primary

Measure	Time frame
Incidence of dose limiting toxicity	—

Secondary

Measure	Time frame
Adverse events, overall survival, progression free survival, response rate, complete response rate	—

Countries

Japan

Contacts

Public ContactMotoo Nomura

Kyoto university Department of Therapeutic Oncology

mnomura@kuhp.kyoto-u.ac.jp075-751-3518

Outcome results

None listed

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