Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Sponsor

Kochi University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05268692

Collaborator

(none)

500

Enrollment

Location

Arms

144

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma	Drug: GS Drug: GnP	Phase 2/Phase 3

Detailed Description

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: GS gemcitabine plus S-1	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.
Active Comparator: GnP gemcitabine plus nab-paclitaxel	Drug: 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.

Arm

Intervention/Treatment

Active Comparator: GS

gemcitabine plus S-1

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.

Active Comparator: GnP

gemcitabine plus nab-paclitaxel

Drug: 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.

Outcome Measures

Primary Outcome Measures

overall survival [5 years]
postoperative survival

Secondary Outcome Measures

adverse events [up to 24 weeks]
incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Takehiro Okabayashi	Kochi		Japan	781-8555

Sponsors and Collaborators

Kochi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Takehiro Okabayashi, Department of Surgery, Kochi University

ClinicalTrials.gov Identifier:

NCT05268692

Other Study ID Numbers:

GSGnP

First Posted:

Mar 7, 2022

Last Update Posted:

Mar 7, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Takehiro Okabayashi, Department of Surgery, Kochi University

Neoadjuvant

Study Results

No Results Posted as of Mar 7, 2022