AzTrials
AzTrials

Pancreatic CancerPhase 3NEOPANCT01900327

Neoadjuvant Treatment in Resectable Pancreatic Cancer

A Phase 3 study testing External Beam Radiation, Gemcitabine neoadjuvant and Surgery in people with Pancreatic Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 16 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
External Beam Radiation, Gemcitabine neoadjuvant and Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
16 sitesGermany
Study dates
Feb 2014to Jul 2017
Phase
Phase 3
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

  • Histology-proven adenocarcinoma of the pancreatic head/uncinate process with a tumor size greater 2 cm (≥cT2) and/or close contact to the superior mesenteric vessels (≤3 mm in preoperative staging).
  • No evidence of metastasis to distant organs (liver, peritoneum, lung, others).
  • For determination of resectability, a multi-detector CT (MDCT) with at least 16 rows applying both oral and intravenous contrast media is performed. MDCT-based imaging focuses on the upper abdomen with native, arterial, and parenchyma phase, where the parenchyma phase should include the pelvis. Imaging criteria derived from the recent consensus definition of the Society of Surgical Oncology, the American Society of Clinical Oncology and the American Hepato-Pancreatico-Biliary Association [1] are applied for preoperative assessment of local resectability.
  • Potential Resectability: visualizable fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric/portal vein (SMV/PV).
  • Borderline Resectability: substantial superior mesenteric/portal vein impingement, tumor abutment on the SMA < 180°, GDA encasement up to the origin of the hepatic artery, or colonic/mesenteric root invasion.
  • Karnofsky performance status ≥ 80%
Show all 11Show fewer
  • Serum creatinine level ≤ 3.0 mg/dl
  • Serum total bilirubin level ≤ 3.0 mg/dl in the absence of biliary obstruction (In the event of biliary obstruction, patients allocated to the CRT group must undergo interventional endoscopy or percutaneous drainage for biliary decompression. Post-interventionally, bilirubin levels should be ≤ 3.0 mg/dl before patients are subjected to CRT. In control patients undergoing upfront surgery, serum total bilirubin levels ≤ 10.0 mg/dl are tolerated, unless clinical and laboratory signs of severe cholangitis take place. Patients with serum total bilirubin level > 10.0 mg/dl undergo preoperative biliary decompression, preferentially by interventional endoscopy)
  • White blood cell count ≥ 3.5 x 109/ml, platelet count ≥ 100 x 109/ml
  • Ability to understand and willingness to consent to formal requirements for study participation
  • Written informed consent

Who cannot join

  • Age ≤ 18 years
  • Neuroendocrine, acinar cancer
  • Cancers of the pancreatic body or tail, i.e. lesions left to the SMV
  • Recurrent disease
  • Infiltration of extrapancreatic organs (except duodenum and transverse colon)
  • Persistent cholestasis/cholangitis despite adequate biliary stenting
Show all 18Show fewer
  • Gastric outlet obstruction, especially in the event of endoscopically evidenced tumor invasion into the gastroduodenal mucosa.
  • Tumor specific pre-treatment
  • History of gastrointestinal perforation, e.g. perforated colonic diverticulitis, abdominal abscess or intestinal fistula within 6 months prior to potential study participation
  • Radiographic evidence of severe portal hypertension/cavernomatous transformation that may, at the discretion of the participating investigators, hamper surgery
  • Other concurrent malignancies except for basal cell cancer of the skin and in-situ cervical cancer
  • Premalignant hematologic disorders, e.g. myelodysplastic syndrome
  • Severe organ dysfunctions (e.g. Liver cirrhosis ≥ Child B; Cardio-pulmonal diseases (NYHA ≥III, arrhythmia Lown III/IV, global respiratory insufficiency); Ascites; Acute pancreatitis; bleeding diathesis, coagulopathy, need for full-dose anticoagulation or INR > 1.5; other severe diseases that might prevent completion of the treatment regimen)
  • Chronic infectious diseases, especially immune deficiency syndromes, e.g. HIV infection, active tuberculosis within 12 months prior to potential study participation
  • History of severe neurologic disorders, e.g. cerebrovascular ischemia
  • History of prior deep venous thrombosis or pulmonary embolism
  • Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months following the trial
  • Serious medical, psychological, familial, sociological or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up Participation in other clinical trials during the last 6 months before allocation to trial

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Germany16 sites

  • Klinikum Augsburg

    Augsburg, Bayer, 86156

  • St. Joseph Hospital Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Darmstadt

    Darmstadt, Hesse, 64283

  • University Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Klinikum Gera

    Gera, Thuringia, 07548

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

  • Hannover Medical School

    Hanover, Lower Saxony, 30625

  • Heidelberg University

    Heidelberg, Baden-Wurttemberg, 69120

  • Saarland University

    Homburg, Saarland, 66421

  • University of Jena

    Jena, Thuringia, 07747

  • Klinikum Karlsruhe

    Karlsruhe, 76133

  • University of Schleswig-Holstein Kiel

    Kiel, Schleswig-Holstein, 24105

  • University of Schleswig-Holstein Lübeck

    Lübeck, Schleswig-Holstein, 23538

  • Technische Universität München

    München, Bavaria, 81675

  • University Regensburg

    Regensburg, Bavaria, 93053

  • University of Rostock

    Rostock, Mecklenburg-Vorpommern, 18057

Other trials in Germany

About this study

Official title: Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma

Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma

Read the detailed description

Median overall-survival (OS) after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months. Tumor recurrence occurs locally, at distant sites (liver, peritoneum, lungs), or both. Observational and autopsy series report local recurrence rates of up to 87% even after potentially "curative" R0 resection. To achieve better local control, neoadjuvant chemo-radiation therapy (CRT) has been suggested for preoperative tumour downsizing, to elevate the likelihood of curative, margin-negative R0 resection and to increase the OS rate. However, controlled, randomized trials addressing the impact of neoadjuvant CRT survival do not exist. The underlying hypothesis of this randomized, two-armed, open-label, multicenter, phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12% (30% to 42%) compared to patients undergoing upfront surgery for resectable pancreatic cancer. Overall, 410 patients (n=205 in each study arm) will be enrolled in the trial, taking into regard an expected drop out rate of 7% and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone. Circumferential resection margin status, i.e. R0 and R1 rates, respectively, surgical resectability rate, local and distant disease-free and global survival, and first site of tumor recurrence constitute further essential endpoints of the trial.

Being tested
External Beam Radiation, Gemcitabine neoadjuvant, Surgery, Gemcitabine adjuvant
Keywords
pancreatic cancer, surgery, chemoradiation, neoadjuvant treatment, overall survival
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • External Beam RadiationRadiation

    Also called External Beam Radiation Therapy, EBRT

    Neoadjuvant CRT with external beam radiation (EBRT) delivering a total dose of 50.4 Gy over 28 days in 1.8 Gy fractions.

  • Gemcitabine neoadjuvantDrug

    Also called Gemcitabin, Gemzar

    weekly Gemcitabine 300mg/m2 for 6 weeks neoadjuvant

  • SurgeryProcedure or surgery

    Also called Tumor resection

    Upfront pancreato-duodenectomy

  • Gemcitabine adjuvantDrug

    Also called Gemcitabin, Gemzar, 2',2'-Difluordesoxycytidin

    Postoperative adjuvant Chemotherapy preferentially using Gemcitabine (1000 mg/m2 6 cycles at day 1, 8, 15 of each 28-day cycle. Administered in both arms, experimental AND active comparator

Study groups in NCT01900327
Study groupRoleWhat they receive
neoadj. TreatmentExperimentalNeoadjuvant CRT with weekly Gemcitabine neoadjuvant 300mg/m2 for 6 weeks combined with external beam radiation (EBRT) delivering a total dose of 50.4 Gy over 28 days in 1.8 Gy fractions will be followed by classical or pylorus-preserving partial pancreato-duodenectomy (PD) and adjuvant chemotherapy (CTx), preferentially using Gemcitabine adjuvant (1000 mg/m2 6 cycles at day 1, 8, 15 of each 28-day cycle).
Receives: Radiation: External Beam Radiation; Drug: Gemcitabine neoadjuvant; Procedure: Surgery; Drug: Gemcitabine adjuvant
Upfront SurgeryActive comparatorUpfront PD followed by adjuvant CTx, preferentially with Gemcitabine adjuvant (1000 mg/m2 6 cycles at day 1, 8, 15 of each 28-day cycle).
Receives: Procedure: Surgery; Drug: Gemcitabine adjuvant

What is being measured

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

  1. 3-Year Survival Rate

    Primary outcome measure is the efficacy of neoadjuvant CRT in improving 3-year survival probability from 30% in the control arm undergoing upfront surgery without neoadjuvant CRT to 42% (relative increase of 40%) in the study arm undergoing CRT. The underlying guess of a 30% 3-year survival probability in the control group derives from an assumed median overall survival (MOS) of 20.7 months which corresponds with a MOS of 17.9 months to 23.6 months reported in several randomized trials.

    Measured: 3 years after last patient in

Secondary outcomes (9)

  1. R0 Resection rate

    Histology-proven R0 resection rate based on a standardized histopathological handling of the surgical specimen.

    Measured: 3 days

  2. Frequency of Toxicity Events

    Frequency of moderate and severe toxicity events and drop-out rate due to therapy related toxicity (NCI Common Toxicity Criteria v2.0)

    Measured: three years

  3. Resectability rate

    Resectability rate

    Measured: one day

  4. Rate of intraoperative irregularities

    Rate of unexpected intraoperative irregularities, operative time, blood transfusion requirement, postoperative morbidity rate, especially that of pancreatic fistula, and mortality rate

    Measured: one day

  5. Postoperative Complications

    Rate of patients with severe postoperative complications (postoperative recovery > 8 weeks) rendering adjuvant treatment worthless

    Measured: three months

  6. Disease progression during neoadjuvant therapy

    Rate of patients with disease progression during neoadjuvant therapy (only applicable in treatment arm)

    Measured: three months

  7. Quality of life

    Quality of life analysis (EORTC QLQ C30 questionnaire). Assessment of QLQ after completion of neoadjuvant RCTx, after surgery (before hospital discharge) and 6, 12 and 18 months after completion of treatment

    Measured: three years

  8. Disease-free Survival

    Median disease-free survival (DFS, local and distant), overall survival (OS)

    Measured: three years

  9. First site of tumor recurrence

    First site of tumor recurrence as determined by abdominal computed tomography during follow-up study visits

    Measured: two years

Timeline

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

  1. First posted16 Jul 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completion22 Nov 2016
  4. Study completionJul 2017

Why it stopped: Recruitment failure

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01900327
Sponsor's protocol ID
NEOPA
Acronym
NEOPA
Status last verified
May 2018
First submitted
27 Jun 2013
Last updated
11 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Tachezy M, Gebauer F, Petersen C, Arnold D, Trepel M, Wegscheider K, Schafhausen P, Bockhorn M, Izbicki JR, Yekebas E. Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma: NEOPA- a randomized multicenter phase III study (NCT01900327, DRKS00003893, ISRCTN82191749). BMC Cancer. 2014 Jun 7;14:411. doi: 10.1186/1471-2407-14-411.

    PubMed 24906700

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing External Beam Radiation, Gemcitabine neoadjuvant and Surgery in people with Pancreatic Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 16 sites 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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 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?

The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.

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?

3-Year Survival Rate (time frame: 3 years after last patient in). 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 NCT01900327, 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 11 May 2018.

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