An investigational study of chemoradiosensitivity prediction with genetic profiling of esophageal biopsy for squamous cell carcinoma of the esophagus

An investigational study of chemoradiosensitivity prediction with genetic profiling of esophageal biopsy for squamous cell carcinoma of the esophagus - Prediction of chemoradiosensitivity with genetic profiling for esophageal squamous cell carcinoma

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000479

Enrollment

160

Registered

2007-02-01

Start date

2007-02-01

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

CDDP 70mg/m2 day1, day 29,5-FU 700mg/m2 day 1-4, day 29-32+radiation 60Gy or CDDP 75mg/m2 day1, day 29, 5-FU 1000mg/m2 day 1-4, day 29-32+radiation 50.4Gy. Salvage surgery for nonCR case

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma of the thoracic esophagus 2) Clinical Stage IIa, IIb, III except T4 3) No previous history of chemotherapy nor radiotherapy 4) Above 20 years old and below 75 years old 5) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 6)Written informed consent obtained before treatment and esophageal biopsy 7) An essentially normal clinical laboratory profile (white blood cell count or WBC, >=4000/mm3; platelet count or Plt, >=100,000/mm3; hemoglobin or Hb >=10g/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT, =<100IU/l; total serum bilirubin=<1.5mg/dl; creatinin or Cr, =<1.2; creatinine clearance or CCr, >=60ml/minute; and saturated arterial oxygen or SpO2, 95% >= ECG, no abnormal findings or no need for treatment

Exclusion criteria

Exclusion criteria: 1) Severe complication (heart failure, renal failure, hepatic failure, uncontrollable diabetes melitus) 2) Active bacterial infection 3) Previous radiotherapy for the chest 4)Interstitial Pneumonitis or pulmonary fibrosis 5) Tumor extend to the cervical esophagus or cardia of the stomach 6) Synchronous or metachronous malignancy 7) Multiple and different histological types of cancer 8) Pregnant female 9) Mental disease 10) Collagen disease (PSS, dermatomiositis ) 11) Tumor diameter, 8cm >= 12) Virus infection (HBV, HCV, PTHA, HIV)

Design outcomes

Primary

Measure	Time frame
1 year disease free survival	—

Secondary

Measure	Time frame
1 year local disease free survival, 3 year disease free survival, 3 year over all survival, pathological complete response	—

Countries

Japan

Contacts

Public ContactYutaka Shimada MD

University of Toyama Department of Surgery & Science

yshimada@med.u-toyama.ac.jp076-434-7331

Outcome results

None listed

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