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Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma

Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma - EC-CPT-P1

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015550
Enrollment
12
Registered
2014-10-28
Start date
2014-10-29
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

Proton beam therapy concurrently with chemotherapy

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma or adenosquamous cell carcinoma 2) Primary lesion are located within the thoracic esophagus 3) Clinical stage IB or II or III (non-T4) 4) Aged 20 to 75 years old 5) ECOG PS of 0 or1 6) adequate organ functions 7) no previous treatment of esophageal cancer except EMR or ESD 8) no previous chemotherapy or radiotherapy against any other malignancies 9) written informed consent

Exclusion criteria

Exclusion criteria: 1. Active double cancer 2. Active infection 3. Body temperature is under 38 centigrade 4. Possible pregnancy 5. Severe psychological disease 6. Systemic steroid user 7. Positive HBs antigen 8. Uncontrolled diabetes 9. Uncontrolled hypertension 10. Unstable angina, cardiac infarction within 6 months before enrollment 11. Interstitial pneumonitis, pulmonary fibrosis, severe emphysema, heart failure 12. Cerebrovascular disease within 6 months before enrollment 13. History of iodine allergy

Design outcomes

Primary

MeasureTime frame
Proportion of dose limiting toxicity

Secondary

MeasureTime frame
Adverse event, Complete response rate

Countries

Japan

Contacts

Public ContactMasakatsu Onozawa

National Cancer Center Hospital East Radation oncology Division

maonozaw@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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