Trials / Completed
CompletedNCT03559348
Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- National Health Research Institutes, Taiwan · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
Multiple centers, uncontrolled, open-label, non-randomized single-arm study
Detailed description
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | chemotherapy: TS-1, Leucovorin and Gemcitabine | Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle. |
Timeline
- Start date
- 2018-04-03
- Primary completion
- 2020-04-20
- Completion
- 2020-04-20
- First posted
- 2018-06-18
- Last updated
- 2022-07-29
Locations
2 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03559348. Inclusion in this directory is not an endorsement.