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Pancreatic Ductal AdenocarcinomaPhase 2NCT02926183

Study of NAC of GA Therapy for Patients With BRPC

A Phase 2 study testing Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Wakayama Medical University at 18 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
18 sitesJapan
Study dates
Oct 2016to Sep 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous
  • Case with measurable lesion
  • First line treatment
  • PS (ECOG) 0-1
  • >= 20 years old and <80 years old
  • The following criteria must be satisfied in laboratory tests within 14 days of registration
Show all 14Show fewer
  • WBC count<=12,000/mm3
  • Neutrophil count>=1,500/mm3
  • Hb >= 9.0g/dl
  • Plt >= 100,000/mm3
  • T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case)
  • Serum Cr<=upper limits of normal (ULN)
  • AST, ALT <= 2.5xULN
  • Written informed consent to participate in this study

Who cannot join

  • Severe drug hypersensitivity
  • Multiple primary cancers within 5 years
  • Severe infection
  • With grade2 or more severe peripheral neuropathy
  • Interstitial pneumonia or pulmonary fibrosis
  • With uncontrollable pleural effusion or ascites
Show all 13Show fewer
  • With uncontrollable diabetes mellitus
  • With uncontrollable heart failure, angina, hypertension, arrhythmia
  • With severe neurological/psychological symptoms
  • With watery diarrhea
  • Pregnant or lactating women or women with unknown or suspected pregnancy
  • Inappropriate patients for entry on this study in the judgement of the investigator
  • Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)

Trial locations and contacts

18 sites in 1 country.

Ken-ichi Okada, M.D., Ph.D. contact

+81-73-441-0613

okada@wakayama-med.ac.jp

18 sites in 1 country

Japan18 sites, 18 recruiting

  • Chiba University

    Chiba

    Hideyuki Yoshitomi, M.D., Ph.D.

    Not yet recruiting

  • Gifu University

    Gifu

    Kazuhiro Yoshida, M.D., Ph.D.

    Not yet recruiting

  • Kansai Medical University

    Hirakata, Osaka

    Sohei Satoi, M.D., PhD

    Not yet recruiting

  • Hirosaki University

    Hirosaki, Aomori

    Keinosuke Ishido, M.D., Ph.D.

    Not yet recruiting

  • Hiroshima University

    Hiroshima

    Yoshiaki Murakami, M.D., PhD.

    Not yet recruiting

  • Nara Medical University

    Kashihara, Nara

    Masayuki Sho, M.D., PhD.

    Not yet recruiting

  • Kobe University

    Kobe, Hyōgo

    Hirochika Toyama, M.D., PhD.

    Not yet recruiting

  • Kumamoto University

    Kumamoto

    Daisuke Hashimoto, M.D., Ph.D.

    Not yet recruiting

  • Kyoto Prefectural University of Medicine

    Kyoto

    Hisashi Ikoma, M.D., PhD

    Not yet recruiting

  • Kyoto University

    Kyoto

    Toshihiko Masui, M.D., Ph.D.

    Not yet recruiting

  • Nagoya University

    Nagoya, Aichi

    Tsutomu Fujii, M.D., PhD.

    Not yet recruiting

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo

    Jiro Fujimoto, M.D., PhD.

    Kazuhiro Suzumura, M.D., PhD.

    Not yet recruiting

  • Osaka City University

    Osaka

    Ryosuke Amano, M.D., PhD.

    Ryosuke Amano, M.D., PhD.

    Not yet recruiting

  • Shiga Medical University

    Ōtsu, Shiga

    Masaji Tani, M.D., Ph.D.

    Not yet recruiting

  • Kinki University

    Sayama, Osaka

    Ippei Matsumoto, M.D., PhD

    Not yet recruiting

  • Osaka University

    Suita, Osaka

    Hidetoshi Eguchi, M.D., Ph.D.

    Not yet recruiting

  • Osaka Medical University

    Takatsuki, Osaka

    Mitsuhiro Asakuma, M.D., Ph.D.

    Not yet recruiting

  • Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera

    Wakayama, 641-8510

    Ken-ichi Okada, M.D., Ph.D., +81-73-441-0613, okada@wakayama-med.ac.jp

    Hiroki Yamaue, M.D., Ph.D.

    Recruiting

Other trials in Japan

About this study

Official title: Phase II Study of Neoadjuvant Chemotherapy of Gemcitabine+Nab-paclitaxel Therapy for Patients With Borderline Resectable Pancreatic Cancer

Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GA regimen.

Read the detailed description

Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GA is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy. On the other hand, incidences of grade 3 or 4 neutropenia, febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate Recurrence free survival from the first day of protocol therapy, safety of the protocol therapy(Adverse effect), morbidity based on Clavien Dindo classification of more than Grade 3, response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT (limited only for PET-CT available institutions), chemotherapeutic effect grade based on Evans classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), the overall morbidity rates (Reoperation, rate of re-admission, mortality), number of patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity for borderline resectable pancreatic cancer.

Being tested
Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxelDrug

    Also called NAC-GA for BRPC

    Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen.

Study groups in NCT02926183
Study groupRoleWhat they receive
Gemcitabine plus nab-paclitaxelExperimentalNeoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel: Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen.
Receives: Drug: Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival time from the first day of protocol therapy

    Measured: Up to 60 months

Secondary outcomes (11)

  1. Recurrence free survival from the first day of protocol therapy

    Measured: Up to 60 months

  2. Adverse effect

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

    Measured: Up to 30 weeks

  3. Morbidity based on Clavien Dindo classification of more than Grade3

    Measured: Up to 30 weeks

  4. Response rate

    Measured: Up to 12 weeks

  5. Chemotherapeutic effect grade based on Evans classification

    Measured: Up to 12 weeks

  6. Resection rate

    Measured: Up to 30 weeks

  7. R0 resection rate

    Measured: Up to 30 weeks

  8. Intraoperative blood loss

    Measured: Up to 30 weeks

  9. The overall morbidity rates based on Clavien Dindo classification

    Measured: Up to 50 weeks

  10. Number of patient rate in postoperative adjuvant therapy

    Measured: Up to 30 weeks

  11. Dose intensity

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionSep 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926183
Sponsor's protocol ID
1881
Status last verified
Oct 2019
First submitted
27 Sep 2016
Last updated
3 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Okada KI, Kimura K, Yamashita YI, Shibuya K, Matsumoto I, Satoi S, Yoshida K, Kodera Y, Akahori T, Hirono S, Eguchi H, Asakuma M, Tani M, Hatano E, Ikoma H, Ohira G, Hayashi H, Wan K, Shimokawa T, Kawai M, Yamaue H; NAC-GA investigators. Efficacy and safety of neoadjuvant nab-paclitaxel plus gemcitabine therapy in patients with borderline resectable pancreatic cancer: A multicenter single-arm phase II study (NAC-GA trial). Ann Gastroenterol Surg. 2023 Jul 8;7(6):997-1008. doi: 10.1002/ags3.12712. eCollection 2023 Nov.

    PubMed 37927936

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Wakayama Medical University at 18 sites 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 14 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ken-ichi Okada, M.D., Ph.D. (+81-73-441-0613, okada@wakayama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival time from the first day of protocol therapy (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02926183, which also lists 1 linked publication.

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 3 Oct 2019.

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