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A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1)

A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1) - IMRT for cervical esophageal cancer (JROSG12-1)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009880
Enrollment
44
Registered
2013-01-28
Start date
2013-02-16
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

cervical esophageal cancer

Interventions

Concurrent chemoradiotherapy with SIB-IMRT (60Gy (prophylactin LN region: 48Gy)/30fr.) and two cycles of chemotherapy (5-FU 700 mg/m2, day 1-4, CDDP 70 mg/m2, day1, q4w) follwed by two cycles of adjuv

Sponsors

Japanese Radiation Oncology Study Group(JROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: i) cervical esophageal cancer with pathologically proven squamous cell carcinoma or adenosquamous cell carcinoma; ii) Clinical stage II-III or IV with supraclavicular LN metastasis (UICC 7th edition, 2009) ; iii) Aged 20 to 75 years old; iv) ECOG PS of 0 to 2; v) No prior chemotherapy against any malignancies; vi) No prior radiotherapy against head and neck or chest region; vii) Screening and diagnosis by an otorhinolaryngologist; viii) Sufficeient organ functions; ix) Written informed consent.

Exclusion criteria

Exclusion criteria: i) Simultaneous or metachronous (within 5 years) double cancers; ii) Systemic infections disease; iii) Body temperature of 38C or higher; iv) Women during pregnancy or breast-feeding; v) Psychiatric disease and/or depression; vi) Continuous systemic steroids medication; vii) HBs antigen positive; viii) Uncontrollable diabetes mellitus; ix) Uncontrollable hypertension; x) Myocardial infarction within 6 months or unstable angina pectoris; xi) Serious complications (interstitial pneumonia, pulmonary fibrosis, COPD, heart failure, etc.); xii) cerebrovasucular disease within 6 months; xiii) Histoty of collagen diseases; xiv) History of surgery of esophagus

Design outcomes

Primary

MeasureTime frame
3 year overall survival

Secondary

MeasureTime frame
3 year progeression-free survival, 3y esophagus preservation rate, 3y larynx preservation rate, early and late adverse event rates

Countries

Japan

Contacts

Public ContactSatoshi Itasaka

JROSG 12-1 Coordinating Office Department of Radiation Oncology, Kurashiki Central Hospital

sitasaka@kchnet.or.jp086-422-0210

Outcome results

None listed

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