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

• Sponsor: National Health Research Institutes, Taiwan (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03443492
• Collaborator: National Taiwan University Hospital (Other), Taipei Veterans General Hospital, Taiwan (Other), China Medical University Hospital (Other), National Cheng-Kung University Hospital (Other), Kaohsiung Medical University (Other), Taipei Medical University Shuang Ho Hospital (Other), Chang Gung Memorial Hospital (Other), Tri-Service General Hospital (Other), E-DA Hospital (Other)
• Enrollment: 130
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.2
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced or Metastatic Pancreatic Cancer	Drug: S-1; Drug: Leucovorin(oral ); Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Irinotecan; Drug: 5-FU; Drug: Leucovorin(IV)	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
• Actual Study Start Date: Mar 26, 2018
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SLOG 800 mg/m2 gemcitabine at a fixed rate of 10 mg/m2/min followed by a 2-hour intravenous infusion of oxaliplatin on day 1 plus twice daily oral S-1 80-120 mg/day (based on BSA) and oral leucovorin 30 mg twice a day on day 1 to day 7, every 14 days as a cycle	Drug: S-1; Intervention is administered to patients in this Arm.; Drug: Leucovorin(oral ); Intervention is administered to patients in this Arm.; Drug: Gemcitabine; Intervention is administered to patients in this Arm.; Drug: Oxaliplatin; Intervention is administered to patients in this Arm.
Experimental: mFOLFIRINOX oxaliplatin at a dose of 85 mg/m2, given as a 2-hour infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute infusion. The treatment was immediately followed by a continuous intravenous infusion via central venous catheter of leucovorin 400 mg/m2 given as a 2-hour infusion and 5-FU 2400 mg/m2 over a 46-hour period on day 1 every 14 days/cycle.	Drug: Oxaliplatin; Intervention is administered to patients in this Arm.; Drug: Irinotecan; Intervention is administered to patients in this Arm.; Drug: 5-FU; Intervention is administered to patients in this Arm.; Drug: Leucovorin(IV); Intervention is administered to patients in this Arm.

Outcome Measures

Primary Outcome Measures

1. progression free survival (PFS) [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.]

   The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

11. WBC ≤ 3 x 10³/mm³

12. ANC ≤ 1.5 x 10³/mm³

13. Platelets ≤ 100.000/mm³

14. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)

15. GFR < 60 mL/min

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

17. Total bilirubin > 2 x ULN

18. Albumin < 2.5 g/dL

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Cancer Research	Miaoli		Taiwan

Sponsors and Collaborators

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

Investigators

• Study Chair: Chen Li-Tzong, National Insitute of Cancer Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Health Research Institutes, Taiwan
• ClinicalTrials.gov Identifier: NCT03443492
• Other Study ID Numbers: T5217
• First Posted: Feb 23, 2018
• Last Update Posted: Aug 22, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Leucovorin; Gemcitabine; Oxaliplatin; Irinotecan; Levoleucovorin

Study Results

No Results Posted as of Aug 22, 2019