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NCT Number: NCT05268692

Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

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.

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Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GS

Drug

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

Drug

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.

Primary outcomes

  1. overall survival

    Time frame: 5 years

    postoperative survival

Secondary outcomes

  1. adverse events

    Time frame: up to 24 weeks

    incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer

Sponsors and collaborators

Lead sponsor

Kochi University

Other

Registry information

Official study title

Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP

Important dates

Study start
2019
Primary completion
2025
Study completion
2030
First posted
Mar 7, 2022
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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