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Split stereotactic body radiation therapy based on chemotherapy for borderline resectable and locally advanced pancreatic cancer: a prospective, single arm phase II trial

Split stereotactic body radiation therapy based on chemotherapy for borderline resectable and locally advanced pancreatic cancer: a prospective, single arm phase II trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024345
Enrollment
Unknown
Registered
2019-07-06
Start date
2019-07-15
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Pancreatic cancer

Interventions

Case series:SBRT WITH CONCURRENT CHEMOTHERAPY

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients, no radiotherapy or chemotherapy before the start of clinical trials; 2. Male or non-pregnant women aged 18-70 years old; 3. Histological or cytologically confirmed pancreatic cancer; 4. According to the Comprehensive Diagnosis and Treatment Guide for Pancreatic Cancer (2018) Edition)" junction can be resected or locally progressed to unresectable pancreatic cancer patients; 6. The maximum diameter of the lesion should not exceed 5 cm; 7. Hematological examination: White blood cell count >=3x10^9/L; Granulocytes >=1.5x10^9/L; Platelet count>=75x10^9/L; Hemoglobin>=100g/L; 8. Blood biochemical examination: AST / SGOT and ALT /SGPT 3 g/dL; Serum creatinine =70 points; 11. Patient's informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1. distant metastasis; 2. Patients with recurrent and distant metastasis; 3. History of other malignant tumors; 4. Have been treated with anti-cancer such as radiotherapy and/or chemotherapy; 5. Pregnancy or lactation women; 6. Spirit Abnormalities; 7. Severe heart, liver, and kidney dysfunction; 8. Gastric or duodenal obstruction 9. Peripheral sensory neuropathy grade > 1; 10. Patient non-compliance or the investigator believes that the patient is unable to complete the entire trial treatment.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
TTF;ORR;OS;TEAE;Surgical resection rate and extent;

Countries

China

Contacts

Public ContactBenhua Xu

Fujian Medical University Union Hospital

benhuaxu@163.com+86 13365910602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026