Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer

Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer - Phase I study of definitive CRT with PCF (PCF-RT) for clinical stage IA-IIIC esophageal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028589

Enrollment

Registered

2017-08-08

Start date

2017-07-26

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

chemoradiotherapy with paclitaxel, CDDP and 5-FU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma or basaloid carcinoma of the esophagus 2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae) 3) Aged 20 to 80 years old 4) ECOG PS of 0 or 1 5) Clinical stage IA-IIIC (UICC-TNM ver.7.0) 6) No need for measurable lesion 7) No previous treatment of esophageal cancer except EMR or ESD 8) No palsy of recurrent nerve 9) Refused esophagectomy 10) Adequate organ functions 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer 2) History of radiotherapy for mediastinum 3) Uncontrollable diabetes millutus 4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure 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 grade 2-4 nerve disturbance by CTCAE version 4.0 11) With blood transfusion within 2 weeks and/or active bleeding 12) Interstitial pneumonia, fibroid lung or severe emphysema 13) With a history of allergic reaction to polyoxy-ethilen oil, hydrogenated castor oil or polysorbate 80 14) Psychosis 15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future 16) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Incidence of dose limiting toxicity	—

Secondary

Measure	Time frame
Adverse events (AE), complete response rate (CRR), progression-free survival (PFS), overall survival(OS)	—

Countries

Japan

Contacts

Public ContactYamamoto Sachiko

Osaka international cancer institute Gastrointestinal oncology

yamamoto-sa@mc.pref.osaka.jp06-6945-1181

Outcome results

None listed

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