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A multi center randomized phase III clinical study of selective lymph nodes radiotherapy vs involved field radiotherapy combined with concurrent S-1 and cisplatin chemotherapy in patients with locally advanced esophageal squamous carcinoma

A multi center randomized phase III clinical study of selective lymph nodes radiotherapy vs involved field radiotherapy combined with concurrent S-1 and cisplatin chemotherapy in patients with locally advanced esophageal squamous carcinoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003547
Enrollment
Unknown
Registered
2013-09-02
Start date
2013-09-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

locally advanced esophageal squamous carcinoma

Interventions

2:involved field radiotherapy combined with concurrent S-1 and cisplatin chemotherapy
1:selective lymph nodes radiotherapy

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) demonstrated pathology as stage II to IVA esophageal squamous cell carcinoma; 2) ECOG scores are 0 - 1 and life expectancy >6 months; 3) age range from 18 to 75 years old; 4) without chemotherapy before inclusion; 5) not received radiotherapy; 6) not received operation treatment; 7) without severe complications; 8) Blood and liver and kidney function: Neutrophil count >=1500/mm3 Blood platelet >=100,000/mm3; Hemoglobin>=100g/l; Transaminase<=2.5 times of the upper limit of normal values; Bilirubin <=1.5 times of the upper limit of normal values; AKP<=5 times of the upper limit of normal values; CR <=1.5mg/dl; 9) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) with other malignant tumor; 2) pregnant or lactating patients; 3) fertility but did not use contraception; 4) serious complications; 5) in other clinical trials now or four weeks before; 6) use other anti-cancer drugs at the same time; 7) had organ transplantation.

Design outcomes

Primary

MeasureTime frame
Local- Regional failure free survial, LRFF;

Secondary

MeasureTime frame
overall survival;progression free survival;local control;regional control;short-term efficacy;side effects;treatment compliance ;

Countries

China

Contacts

Public ContactBaosheng Li

Shandong Cancer Hospital

baoshli@yahoo.com+86 0531 67626161

Outcome results

None listed

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