Pancreatic AdenocarcinomaPhase 2/3NCT05268692
Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP
A Phase 2/3 study testing GS and GnP in people with Pancreatic Adenocarcinoma, run by Kochi University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- GS and GnP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2019to 31 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective pancreatectomy for pancreatic cancer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Takehiro Okabayashi
Kochi, 781-8555
Takehiro Okabayashi, +81- 88-837-3000, tokabaya@gmail.com
About this study
Official title: Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. 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.
Read the detailed description
gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- GS, GnP
- Keywords
- Neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSDrug
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.
GnPDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| GS | Active comparator | gemcitabine plus S-1 Receives: Drug: GS |
| GnP | Active comparator | gemcitabine plus nab-paclitaxel Receives: Drug: GnP |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
postoperative survival
Measured: 5 years
Secondary outcomes (1)
adverse events
incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiro Okabayashi, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268692
- Sponsor's protocol ID
- GSGnP
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP
- ClinicalTrials.gov ID
- NCT05268692
- Acronym / sponsor ID
- GSGnP
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Neoadjuvant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS | Active comparator | Drug: GSgemcitabine plus S-1 |
| GnP | Active comparator | Drug: GnPgemcitabine plus nab-paclitaxel |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective pancreatectomy for pancreatic cancer
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSdrip 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. | Drug | GS |
| GnPdrip 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. | Drug | GnP |
Primary outcome
overall survival
Time frame: 5 years
postoperative survival
1 secondary outcome
adverse events
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
Related trials for Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GS and GnP in people with Pancreatic Adenocarcinoma, run by Kochi University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.