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Management of advanced esophageal cancer patients received chemotherapy using early ctDNA dynamics

Management of advanced esophageal cancer patients received chemotherapy using early ctDNA dynamics - CHANGE-ES01 study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047559
Enrollment
60
Registered
2022-04-25
Start date
2022-02-28
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

Patients without ctDNA decrease before and after the initial cycle of chemotherapy (post-/pre-ctDNA: equal or more than 10%): treatment change based on the efficacy evaluation of chemotherapy using co
Group C)

Sponsors

Division of Biomedical Research and Development, Institute of Biomedical Sciences, Iwate Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with Stage III/IV or recurrent esophageal cancer planning to chemotherapy with docetaxel, cisplatin and 5-FU or CDDP and 5-FU as the first line therapy 2) Histologically diagnosed esophageal carcinoma 3) Primary tumor located in thoracic esophagus. Tumor which is centrally located more than 2 cm below of the esophago-gastric junction is ineligible 4) ECOG performance status: 0-2 5) More than 2 treatments regimens are remained 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous malignancies except for early cancer which will not affect prognosis. 2) Patients with active infection with fever requiring a systematic therapy

Design outcomes

Primary

MeasureTime frame
2-year overall survival rates

Secondary

MeasureTime frame
1) Progression free survival rates 2) ctDNA dynamics and change of tumor burden 3) Quality of life, Quality-adjusted life years

Countries

Japan

Contacts

Public ContactTakeshi Iwaya

Iwate Medical University School of Medicine Department of Surgery

tiwaya@iwate-med.ac.jp019-613-7111

Outcome results

None listed

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