Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Pancreatic Adenocarcinoma Clinical Trial

Official title:

Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268692
• Other study ID #: GSGnP
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2019
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2022
• Source: Kochi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.

Description:

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

elective pancreatectomy for pancreatic cancer

Exclusion Criteria:

a previous cancer surgery a body weight loss of >10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.

Related Conditions & MeSH terms

• Pancreatic Adenocarcinoma

Intervention

Drug:
• GS
drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (< 1.25 m2, 60 mg/d; = 1.25 to < 1.5 m2, 80 mg/d; = 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-day cycle gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1 and 8of a 21-day cycle.
• GnP
drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. nab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.

Locations

Country	Name	City	State
Japan	Takehiro Okabayashi	Kochi

Sponsors (1)

Lead Sponsor	Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	postoperative survival	5 years
Secondary	adverse events	incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer	up to 24 weeks