Locally Advanced or Metastatic Pancreatic Adenocarcinoma

NCT ID: NCT03559348

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2020-04-20

Brief 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

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biweekly TS-1, Leucovorin and Gemcitabine (GSL)

Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle

Group Type: EXPERIMENTAL

chemotherapy: TS-1, Leucovorin and Gemcitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.

2. Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.

3. Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.

4. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.

5. Baseline ECOG performance status is 2.

6. Patients have life expectancy of at least 12 weeks.

7. Patients have age 70 years.

8. Patients have adequate organ function.

9. Patients with biliary obstruction which is adequate drained before enrollment are eligible.

10. Patients agree to have an indwelling venous catheter implanted.

11. Women or men of reproductive potential should agree to use an effective contraceptive method.

12. All patients must be informed of the investigational nature of this study and must sign written informed consents.

Exclusion Criteria

1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.

2. Patients with metastatic lesion in central nervous system.

3. Patients with active infection.

4. Patients with active cardiopulmonary disease or history of ischemic heart disease.

5. Patients who have peripheral neuropathy > grade I of any etiology.

6. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.

7. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Chang-Gung Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

T1217

Identifier Type: -

Identifier Source: org_study_id