N/A
N=63
Combination of SBRT With Sequential S-1 for Treating Locally Advanced Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02704143 ↗Enrolled (actual)
63
Serious AEs
9.5%
Results posted
Jul 2020
Primary outcome: Primary: One-year Overall Survival Rate — 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- combination of Cyberknife with S-1 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Changhai Hospital
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY One-year Overall Survival Rate |
46 | — |
| SECONDARY Number of Participants With Acute Toxicities Following SBRT |
9 | — |
| SECONDARY Number of Participants With Late Toxicities Following SBRT |
5 | — |
| SECONDARY The Median Progression Free Survival Time Will be Determined. |
10.1 | — |
| SECONDARY The Quality of Life Will be Analyzed. |
50.0; 64.2; 54.8; 68.5; 73.8; 74.6 | — |
| SECONDARY Median Overall Survival Will be Determined. |
14.4 | — |
Summary
The safety and efficacy of combination of SBRT with sequential S-1 in treating patients with locally advanced pancreatic cancer and poor medical conditions will be evaluated.
Eligibility Criteria
Inclusion Criteria
- Locally advanced pancreatic cancer proved by CT or MRI and biopsy
- Without any other treatment before SBRT
- A life expectancy of >3months
- ECOG: 2 or 3 points
- Age of more than 18 years old
- Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×10^9 cells/L, leukocyte count≥ 3.5 ×10^9 cells/L, platelets ≥ 70×10^9 cells/L, hemoglobin ≥ 8.0 g/dl
- Liver and kidney function tests: Albumin > 2.5 g/dL, total bilirubin < 3 mg/dL, creatinine < 2.0 mg/dL, AST<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT<2.5 × ULN(0-64U/L)
- INR < 2 (0.9-1.1)
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Prior surgery, chemotherapy or radiation for the pancreatic cancer
- Evidences of metastatic disease such as nodal or distant metastases by abdomen CT and chest CT or FDG PET-CT
- Contraindication to receiving radiotherapy
- ECOG: 0-1 point
- Age<18
- Abnormal results of blood routine examinations and liver and kidney tests
- Patients with active inflammatory bowel diseases or peptic ulcer
- Gastrointestinal bleeding or perforation within 6 months
- Heart failure: NYHA III-IV
- Women who are pregnant
- Participation in another clinical treatment trial while on study
- Patients in whom fiducial implantation was not possible
- Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Data sourced from ClinicalTrials.gov (NCT02704143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.