SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer

Locally Advanced or Metastatic Pancreatic Cancer Clinical Trial

— Pancreas  

Official title:

A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03443492
• Other study ID #: T5217
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: March 26, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase II Randomized Study.Primary objective:to investigate the 6-month progression-free survival (PFS) rate i patients receiving SLOG or mFLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer.

Description:

A total of 130 patients (65patients in each arm) will be calculated, based on the assumption of a 6-month PFS rate of 45% with mFOLFIRINOX vs 60% wuth SLOG, to achieve 75% power, with a drop-out rate of 10%. Two-sided test was performed with type I error=0.10.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients must have cyto-/histologically confirmed, locally advanced unresectable or metastatic adenocarcinoma of the pancreas (mPAC). Patients who have disease measurable or evaluable on x-ray, CT scan, or physical examination are eligible.

2. Patients must have no history of prior chemotherapy for PAC, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.

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

4. Patients' baseline ECOG performance status must be 1.

5. Patients' life expectancy 12 weeks or greater.

6. Patients' age 20 and 80.

7. Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.

8. Patients must agree to have indwelling venous catheter implanted.

9. Women or men and their partners of reproductive potential should agree to use an effective contraceptive method.

10. All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

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 2 weeks after the completion of radiotherapy.

2. Patients with central nervous system metastasis

3. Patients with active infection

4. Pregnant or breast-nursing women

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

6. Patients who have peripheral neuropathy > Grade I of any etiology

7. 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.

8. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment

9. Patients who are under biologic treatment for their malignancy

10. Laboratory tests (hematology, chemistry) outside specified limits:

1. WBC = 3 x 10³/mm³

2. ANC = 1.5 x 10³/mm³

3. Platelets = 100.000/mm³

4. Hb = 9.0 g/dl (= 5.6 mmol/l)

5. GFR < 60 mL/min

6. AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN

7. Total bilirubin > 2 x ULN

8. Albumin < 2.5 g/dL

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• S-1
Intervention is administered to patients in this Arm.
• Leucovorin(oral )
Intervention is administered to patients in this Arm.
• Gemcitabine
Intervention is administered to patients in this Arm.
• Oxaliplatin
Intervention is administered to patients in this Arm.
• Irinotecan
Intervention is administered to patients in this Arm.
• 5-FU
Intervention is administered to patients in this Arm.
• Leucovorin(IV)
Intervention is administered to patients in this Arm.

Locations

Country	Name	City	State
Taiwan	National Institute of Cancer Research	Miaoli

Sponsors (10)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, China Medical University Hospital, E-DA Hospital, Kaohsiung Medical University, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taipei Medical University Shuang Ho Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival (PFS)	The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)	Since this is an exploratory trial, it takes a sample size of 61 patients per arm entered in 2 years with a minimum 1 year of follow up to reach 75% power with type I error of 10% under the assumptions of exponential survival functions.