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A multicenter phase III randomized study of the locally advanced thoracic esophageal squamous carcinoma treated with concurrent chemoradiation of different doses (50.4 Gy vs. 59.4 Gy) anddifferent target (elective nodal irradiation vs. involved field irradiation)

A multicenter phase III randomized study of locally advanced thoracic esophageal squamous carcinoma treated with concurrent chemoradiation of different doses (50.4 Gy vs. 59.4 Gy) anddifferent target (elective nodal irradiation vs. involved field irradiation)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007172
Enrollment
Unknown
Registered
2015-09-28
Start date
2015-10-30
Completion date
Unknown
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Group A:elective nodal irradiation (50.4Gy)
Group B:elective nodal irradiation (59.4Gy)
Group C:involved field irradiation (50.4Gy)
Group D:involved field irradiation (59.4Gy)

Sponsors

Shandong cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) the histopathological proofed II - IVa thoracic esophageal squamous cell carcinomas (UICC 2002); 2) ECOG 0-1 level;Life expectancy > 6 months; 3) aged 18 to 70 years old, men or women; can drink the liquid at least; 4) No chemotherapy; 5) No radiotherapy; 6) No surgery; 7) without severe allergies; 8) hemoglobin>100 g/L, the WBC>3.5*10^9/L, neutrophils>1.5*10^9, platele>100*10^9/L; CR<1.5*Upper limit of normal, TB<2.5*Upper limit of normal, AST andALT<2.5*Upper limit of normal, AKP<2.5*Upper limit of normal; 9) barium meal lesion length<10 cm; 10) signed informed consent.

Exclusion criteria

Exclusion criteria: 1) A history of other malignant tumor; 2) repeat esophageal cancer; 3) pregnant or lactating patients; 4) have fertility but did not use contraception; 5) serious complications: extremely high risk of high blood pressure, serious lung function damage, large area of myocardial infarction, cardiac function class II or higher, mental illness or severe diabetes; 6) activity of infectious diseases; 7) participated in other clinical trials 4 weeks prior to the trial; 8) at the same time with other anticancer drug therapy (including anticancer Chinese traditional medicine); 9) after esophageal stent surgery; 10) has a tendency to perforation; 11) has a history of organ transplantation.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
local-region failure free survival;progression free survival;local-region control rate;treatment toxicity;

Countries

China

Contacts

Public ContactBaosheng Li
baoshli163@163.com+86 531-67626161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026