AzTrials
AzTrials

Resectable Pancreatic CancerPhase 2NEONAXNCT02047513

Neoadjuvant Plus Adjuvant or Only Adjuvant Nab- Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer

A Phase 2 study testing perioperative nab-paclitaxel/gemcitabine and adjuvant nab-paclitaxel/gemcitabine in people with Resectable Pancreatic Cancer and Ductal Adenocarcinoma of the Pancreas, run by AIO-Studien-gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

NEONAX is an interventional, prospective, randomized, controlled, open label, two sided survival phase II studies against a fixed survival probability, with an unconnected analysis of the results in both experimental arms. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
perioperative nab-paclitaxel/gemcitabine and adjuvant nab-paclitaxel/gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteGermany
Study dates
Jul 2015to Oct 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytological confirmed, clearly resectable ductal adenocarcinoma of the pancreas (PDAC) ≤ cT3 with no prior tumor specific treatment.
  • No evidence of metastases to distant organs (e.g. liver, peritoneum, lung).
  • Resectable tumor. Determination of resectability based on spiral CT scans with both oral and i.v. contrast enhancement or on MRI using a recent consensus definition (Resectability: Clear fat planes around the celiac artery, hepatic artery and superior mesenteric artery.)
  • Measurable tumor according to RECIST 1.1
  • ECOG performance status 0 or 1
  • Creatinine clearance ≥ 30 ml/min
Show all 12Show fewer
  • Serum total bilirubin level ≤ 2.5 x ULN (not necessary for enrollment or randomization, but before start of neoadjuvant chemotherapy in arm A)
  • ALT and AST ≤ 2.5 x ULN (not necessary for enrollment or randomization, but before start of neoadjuvant chemotherapy in arm A)
  • In case of biliary obstruction, biliary decompression is required if the patient was randomized to receive neoadjuvant chemotherapy (arm A)
  • White blood cell count ≥ 3.5 x 106/ml, neutrophil granulocytes count ≥ 1,5 x 106/ml, platelet count ≥ 100 x 106/ml
  • Signed informed consent incl. participation in translational research
  • Age ≥ 18 years

Who cannot join

  • Borderline resectable PDAC by radiologic criteria
  • Papillary cancer
  • Neuroendocrine Cancer
  • Tumor specific pre-treatment
  • Local recurrence
  • Peritoneal or other distant metastases
Show all 31Show fewer
  • Radiographic evidence of severe portal hypertension/cavernous transformation
  • Infiltration of extrapancreatic organs (except duodenum)
  • Ascites
  • Gastric outlet obstruction
  • Global respiratory insufficiency requiring oxygen supplementation
  • Chronic infectious diseases, immune deficiency syndromes
  • Premalignant hematologic disorders, e.g. myelodysplastic syndrome
  • Disability to understand and sign written informed consent document
  • Past or current history of malignancies except for the indication under this study and curatively treated:
  • Basal and squamous cell carcinoma of the skin
  • In-situ carcinoma of the cervix
  • Other malignant disease without recurrence after at least 2 years of follow-up
  • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
  • Clinically relevant or history of interstitial lung disease, e.g. non-infectious pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan or chest x-ray.
  • History of or evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumor, seizure not controlled with standard medical therapy or history of stroke).
  • Pre-existing neuropathy > grade 1 (NCI CTCAE)
  • Allogeneic transplantation requiring immunosuppressive therapy or other major immunosuppressive therapy
  • Severe non-healing wounds, ulcers or bone fractions
  • Evidence of bleeding diathesis or coagulopathy
  • Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and PTT < 1.5 ULN within 28 days prior to randomization. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution)
  • Major surgical procedures, except open biopsy, nor significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgical procedure during the course of the study except for surgery of pancreatic cancer with curative intent and central intravenous line placement for chemotherapy administration.
  • Pregnancy or breastfeeding women.
  • Subjects with known allergies to the study drugs or to any of its excipients.
  • Current or recent (within the 28 days prior randomization) treatment with another investigational drug or participation in another investigational study.
  • Any psychological, familial, sociological or geographical condition potentially compromising compliance with the study protocol and the follow-up schedule; those conditions should be discussed with the patient prior to registration in the trial

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Ulm, Dept. of Internal Medicine I

    Ulm, 89081

Other trials in Germany

About this study

Official title: Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer: A Prospective, Randomized, Controlled, Phase II Study of the AIO (Working Group for Medical Oncology From the German Cancer Society) Pancreatic Cancer Group

NEONAX is an interventional, prospective, randomized, controlled, open label, two sided survival phase II studies against a fixed survival probability, with an unconnected analysis of the results in both experimental arms.

Determining the impact of 2 cycles of Perioperative nab-paclitaxel/gemcitabine followed by surgery and 4 cycles of adjuvant nab-paclitaxel/gemcitabine or 6 cycles of adjuvant nab-paclitaxel/gemcitabine on the Disease free survival (DFS) rate at 18 months post randomization

Read the detailed description

The planned trial will enable us to address the following issues:

  • Identification of patients who benefit from surgery. Tumor progress during intensified Perioperative chemotherapy is likely to indicate a particularly poor prognosis suggesting that these patients would not have benefitted from immediate surgery.
  • Assess tumor response/downsizing using nab-paclitaxel/gemcitabine also at the molecular level
  • Can we achieve a better systemic tumor control or reduce the metastatic spread using nab-paclitaxel/gemcitabine compared to adjuvant gemcitabine
  • Examining the effect of a more efficacious chemotherapy regimen (nab-paclitaxel/gemcitabine) in the adjuvant setting
  • Defining the impact of a perioperative or adjuvant chemotherapy with gemcitabine/nab-paclitaxel on DFS and 3-year Overall survival (OS)

Histopathological tumor regression will be evaluated in addition to tumor size measurement according to Response Evaluation Criteria In Solid Tumors (RECIST). We will establish a histopathological tumor regression score to evaluate the efficacy of the neoadjuvant treatment. For this score we will examine tumor core biopsies obtained prior to neoadjuvant treatment and histological tumor specimen after surgery in both arms.

To reliably determine R0 resections, the resected specimen will be prepared for pathology in a defined manner according to the procedure set out in the German S3 guidelines for pancreatic cancer.

This trial provides the unique opportunity in pancreatic cancer to obtain material prior to and after surgery for biomarker analysis and correlation with outcome. We will perform pharmacogenomic candidate gene analysis of hENT1 (human equilibrative nucleoside transporter-1), CDA (cell differentiation agent), DCK (Desoxycytidin-Kinase) and 5´nucleotidase in both arms.

Being tested
perioperative nab-paclitaxel/gemcitabine, adjuvant nab-paclitaxel/gemcitabine

What participants receive

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

  • perioperative nab-paclitaxel/gemcitabineDrug

    2 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles) followed by 3 weeks of rest and subsequent tumor surgery. Starting within 12 weeks after surgery adjuvant chemotherapy with 4 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles)

  • adjuvant nab-paclitaxel/gemcitabineDrug

    Tumor surgery followed by adjuvant chemotherapy with 6 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles, starting within 12 weeks after surgery)

Study groups in NCT02047513
Study groupRoleWhat they receive
perioperative nab-paclitaxel/gemcitabineExperimentalneoadjuvant chemotherapy (8 weeks) preceding surgery (3 weeks after completion of chemotherapy) followed by adjuvant chemotherapy (16 weeks, begin within 12 weeks after surgery)
Receives: Drug: perioperative nab-paclitaxel/gemcitabine
adjuvant nab-paclitaxel/gemcitabineExperimentalSurgery followed by adjuvant chemotherapy (24 weeks, begin within 12 weeks after surgery), follow-up per patient: Until end of study or death
Receives: Drug: adjuvant nab-paclitaxel/gemcitabine

What is being measured

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

  1. Time to Disease free survival (DFS)

    To improve the DFS rate at 18 months in at least one arm to≥ 55%

    Measured: 18 months after randomization

Secondary outcomes (14)

  1. Safety

    • Safety of nab-paclitaxel/gemcitabine in the neoadjuvant and adjuvant setting

    Measured: 57 months

  2. morbidity and mortality

    • pre- and postoperative morbidity and mortality in both studies

    Measured: 7 years

  3. toxicity

    • Dropout rate due to toxicity in the neoadjuvant study

    Measured: 57 months

  4. Disease progression

    • Disease progression during neoadjuvant therapy

    Measured: 7 years

  5. resection rate

    • R0 and R1 resection rate in both groups as assessed according to the German S3 guidelines

    Measured: 53 months

  6. Tumor response

    • Tumor response according to RECIST v1.1; histopathological regression based on a predefined pathological handling of the resected specimen in the perioperative study

    Measured: 57 months

  7. Correlation of tumor regression and R0 resection

    • Correlation of tumor regression and R0 resection rate with response according to RECIST v1.1 in the perioperative study

    Measured: 57 months

  8. Overall survival

    • Overall survival in both studies

    Measured: 7 years

  9. tumor recurrence

    • First site of tumor recurrence in both studies

    Measured: 7 years

  10. quality of life

    • Explorative analysis of health related quality of life in both studies

    Measured: 57 months

  11. pharmacogenomic markers, tumor-biomarkers and molecular analyses

    • Correlation of DFS, OS and tumor regression with pharmacogenomic markers, tumor-biomarkers and molecular analyses in both studies

    Measured: 57 months

  12. Safety

    • Assessment of safety

    Measured: 57 months

  13. Tumor response

    To assess tumor response using the imaging data (CT scans, MRI-scans) obtained during the trial

    Measured: 66 months

  14. Tumor recurrence

    To assess tumor recurrence using the imaging data (CT scans, MRI-scans) obtained during the trial

    Measured: 66 months

Timeline

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

  1. First posted28 Jan 2014 (estimated)
  2. Study startJul 2015
  3. Primary completionApr 2021
  4. Study completionOct 2022

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02047513
Sponsor's protocol ID
AIO-PAK-0313
Other IDs
2013-005559-34, AX_CL_PANC_AIO_003710
Acronym
NEONAX
Status last verified
Jun 2023
First submitted
9 Jan 2014
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Seufferlein T, Uhl W, Kornmann M, Algul H, Friess H, Konig A, Ghadimi M, Gallmeier E, Bartsch DK, Lutz MP, Metzger R, Wille K, Gerdes B, Schimanski CC, Graupe F, Kunzmann V, Klein I, Geissler M, Staib L, Waldschmidt D, Bruns C, Wittel U, Fichtner-Feigl S, Daum S, Hinke A, Blome L, Tannapfel A, Kleger A, Berger AW, Kestler AMR, Schuhbaur JS, Perkhofer L, Tempero M, Reinacher-Schick AC, Ettrich TJ. Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)-a randomized phase II trial of the AIO pancreatic cancer group. Ann Oncol. 2023 Jan;34(1):91-100. doi: 10.1016/j.annonc.2022.09.161. Epub 2022 Oct 7.

    PubMed 36209981

  • Ettrich TJ, Berger AW, Perkhofer L, Daum S, Konig A, Dickhut A, Wittel U, Wille K, Geissler M, Algul H, Gallmeier E, Atzpodien J, Kornmann M, Muche R, Prasnikar N, Tannapfel A, Reinacher-Schick A, Uhl W, Seufferlein T. Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group. BMC Cancer. 2018 Dec 29;18(1):1298. doi: 10.1186/s12885-018-5183-y.

    PubMed 30594153

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing perioperative nab-paclitaxel/gemcitabine and adjuvant nab-paclitaxel/gemcitabine in people with Resectable Pancreatic Cancer and Ductal Adenocarcinoma of the Pancreas, run by AIO-Studien-gGmbH at 1 site in Germany.

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 12 inclusion and 31 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: finished, as of the sponsor's last update on 15 Jun 2023. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Disease free survival (DFS) (time frame: 18 months after randomization). 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 NCT02047513, which also lists 2 linked publications.

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 15 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in