Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

NCT05268692 | Recruiting Phase 2 DMC

• 1 other identifier: GSGnP
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• overall survival

  postoperative survival

  5 years

Secondary Outcomes (1)

• adverse events

  up to 24 weeks

Study Arms (2)

GS

ACTIVE COMPARATOR

gemcitabine plus S-1

Drug: GS

GnP

ACTIVE COMPARATOR

gemcitabine plus nab-paclitaxel

Drug: GnP

Interventions

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.

GS

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.

GnP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective pancreatectomy for pancreatic cancer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kochi University: lead

Study Sites (1)

Takehiro Okabayashi

Kochi, 781-8555, Japan

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Surgery

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 7, 2022
• Study Start: January 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

JP (1)