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Phase II study of adjuvant S-1 concurrent radiotherapy in pancreatic cancer patients with high risk factors

Phase II study of adjuvant S-1 concurrent radiotherapy in pancreatic cancer patients with high risk factors

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-13003060
Enrollment
Unknown
Registered
2013-01-03
Start date
2013-01-01
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

Pancreatic Cancer

Interventions

treatment group:external beam radiotherapy
treatment group:chemotherapy with S-1

Sponsors

Zhongshang Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) aged 18-75 years; 2) 3 to 10 weeks after surgical resection; 3) ECOG performance status (PS) 0–2; 4) with 1 or more high risk fators: pT3 or pN1, positive-margin, perineural invasion, Peritumor intravascular cancer emboli; 5) adequate bone marrowhemoglobin:>=110g/L, absolute neutrophil count (ANC)>=1.5*10^9/L, platelet count>=100*10^9/L; 6) kidney function (serum creatinine<=115umol/L) and liver function (serum total bilirubin<=34umol/L).

Exclusion criteria

Exclusion criteria: 1) With distant metastatic disease; 2) With unrecovered postoperative complications; 3) Patients with prior malignancy were ineligible for the study, with the exception of those who had experienced nonmelanoma skin cancer, in situ cancer of the cervix, or other cancer for which the patient had been disease free >=5 yrs. 4) Had received abdominal irradiation before; 5) Poor compliance.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Secondary

MeasureTime frame
Disease-free survival;

Countries

China

Contacts

Public ContactLou Wenhui
lou.wenhui@zs-hospital.sh.cn+86 13681971683

Outcome results

None listed

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