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A multicenter phase II randomized study of elderly patients with esophageal squamous carcinoma treated with S-1 with concurrent radiotherapy vs. radiotherapy alone

A multicenter phase II randomized study of elderly patients with esophageal squamous carcinoma treated with S-1 with concurrent radiotherapy vs. radiotherapy alone

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17010668
Enrollment
Unknown
Registered
2017-02-17
Start date
2017-04-01
Completion date
Unknown
Last updated
2021-07-05

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:S-1 with concurrent radiotherapy
Group B:radiotherapy only

Sponsors

Shandong cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

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; CR70%; 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) 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; 4) activity of infectious diseases; 5) participated in other clinical trials 4 weeks prior to the trial; 6) at the same time with other anticancer drug therapy (including anticancer Chinese traditional medicine); 7) after esophageal stent surgery; 8) has a tendency to perforation; 9) has a history of organ transplantation.

Design outcomes

Primary

MeasureTime frame
treatment toxicity;objective remission rate;

Secondary

MeasureTime frame
overall survival;progression free survival;

Countries

China

Contacts

Public ContactBaosheng Li

Shandong Cancer Hospital

baoshli163@163.com+86 531-67626161

Outcome results

None listed

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