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Pancreatic NeoplasmsPhase 1/2NEOPANCNCT01372735

Trial of Neoadjuvant Short Course IMRT Followed by Surgery and IORT for Resectable Pancreatic Cancer

A Phase 1/2 study testing neoadjuvant short course IMRT and IORT in people with Pancreatic Neoplasms, run by University Hospital Heidelberg at 3 sites in Germany.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The current standard treatment for patients with primarily resectable pancreatic tumors consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable group, long term survival is disappointing because of high local and distant failure rates. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
neoadjuvant short course IMRT and IORT
Type of treatment
Surgery or procedure
How many people
46 participants
Where
3 sitesGermany
Study dates
Aug 2011to Aug 2017
Phase
Phase 1/2
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • written informed consent
  • histologically confirmed, primary pancreatic cancer of the pancreatic head
  • judged as gross completely resectable
  • absence of lymph node metastases at the splenic hilum or along the pancreatic tail
  • no evidence of distant metastases
  • age > 50 years
Show all 10Show fewer
  • Karnofsky performance score ≥ 70%
  • adequate bone marrow function (neutrophils > 2000/µl, platelets > 100000/µl)
  • adequate renal function (Creatinine < 1.5 mg/dl)
  • adequate liver function

Who cannot join

  • missing written informed consent
  • missing histological conformation of pancreatic cancer
  • judged as gross incomplete or not resectable
  • pancreatic cancer located in the pancreatic corpus or tail
  • recurrent pancreatic cancer
  • incomplete staging
Show all 21Show fewer
  • presence of lymph node metastases along the pancreatic tail or splenic hilum
  • presence of distant metastases
  • prior radiation therapy to the upper abdominal region
  • neoadjuvant chemotherapy or immunotherapy
  • participation in another clinical interventional study
  • age ≤ 50 years
  • other previous or active malignancy (excluding basal cell carcinoma, carcinoma in situ of the cervix)
  • Karnofsky performance score <70%
  • inadequate bone marrow function
  • inadequate renal or liver function
  • any other disease or situation, which generally prohibits the use of major surgery or radiation therapy according to the judgement of a surgeon or radiation oncologist
  • inability to participate in regular follow up
  • pregnancy, inability or incompliance for adequate contraception
  • missing ability to give informed consent
  • legal custody

Trial locations and contacts

3 sites in 1 country.

Falk FF Roeder, MD contact

+4962215639587

Falk.Roeder@med.uni-heidelberg.de

Peter E Huber, MD, PhD contact

+496221422515

P.Huber@dkfz.de

Germany3 sites

  • Department of Radiation Oncology, German Cancer Research Center

    Heidelberg, 69120

    Peter E Huber, MD, PhD, +496221422515, P.Huber@dkfz.de

    Peter E Huber, MD, PhD

  • Department of Radiation Oncology, University Hospital Heidelberg

    Heidelberg, 69120

    Falk FF Roeder, MD, +4962215639587, Falk.Roeder@med.uni-heidelberg.de

    Falk FF Roeder, MD

  • Department of Surgery, University of Heidelberg

    Heidelberg, 69120

    Jens Werner, MD, +4962215639692, Jens.Werner@med.uni-heidelberg.de

    Jens Werner, MD

Other trials in Germany

About this study

Official title: Clinical Phase I/II Trial to Investigate Neoadjuvant Intensity-Modulated Short Term Radiation Therapy (5x5 Gy) and Intraoperative Radiation Therapy (15 Gy) in Patients With Primarily Resectable Pancreatic Cancer - NEOPANC

The current standard treatment for patients with primarily resectable pancreatic tumors consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable group, long term survival is disappointing because of high local and distant failure rates. Postoperative chemoradiation has shown improved local control and overall survival compared to surgery alone but the value of additional radiation has been questioned in case of adjuvant chemotherapy. However, there remains a strong rationale for the addition of radiation therapy considering the high rates of microscopically incomplete resections after surgery. As postoperative administration of radiation therapy has some general disadvantages, neoadjuvant and intraoperative approaches theoretically offer benefits in terms of dose escalation, reduction of toxicity and patients comfort especially if hypofractionated regimens with highly conformal techniques like intensity-modulated radiation therapy are considered.

Therefore the NEOPANC trial has been designed as a prospective, one armed single center study to investigate a combination of neoadjuvant short course intensity-modulated radiation therapy (5x5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy) followed by adjuvant chemotherapy according to german treatment guidelines in patients with primarily resectable pancreatic cancer. The primary objectives of the NEOPANC trial are to evaluate the general feasibility of this approach and the local recurrence rate after one year. Secondary endpoints are progression-free survival, overall survival, acute and late toxicity, postoperative morbidity and mortality and quality of life.

Being tested
neoadjuvant short course IMRT, IORT
Keywords
pancreatic cancer, intensity-modulated radiation therapy, intraoperative radiation therapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • neoadjuvant short course IMRTRadiation

    neoadjuvant short course intensity-modulated radiotherapy, single dose 5 Gy, total dose 25 Gy (5x5 schedule) to primary tumor and regional lymph nodes

  • IORTRadiation

    intraoperative radiation therapy during resection, 15 Gy (to 90% isodose) to tumor bed

What is being measured

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

  1. Local recurrence rate

    Measured: 1 year

Secondary outcomes (2)

  1. Progression-free Survival

    Measured: up to 5 years from first day of treatment

  2. Overall Survival

    Measured: up to 5 years from first day of treatment

Timeline

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

  1. First posted14 Jun 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2013 (estimated)
  4. Study completionAug 2017 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01372735
Sponsor's protocol ID
NEOPANC
Acronym
NEOPANC
Status last verified
Jun 2011
First submitted
9 Jun 2011
Last updated
14 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Roeder F, Timke C, Saleh-Ebrahimi L, Schneider L, Hackert T, Hartwig W, Kopp-Schneider A, Hensley FW, Buechler MW, Debus J, Huber PE, Werner J. Clinical phase I/II trial to investigate neoadjuvant intensity-modulated short term radiation therapy (5 x 5 Gy) and intraoperative radiation therapy (15 Gy) in patients with primarily resectable pancreatic cancer - NEOPANC. BMC Cancer. 2012 Mar 23;12:112. doi: 10.1186/1471-2407-12-112.

    PubMed 22443802

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing neoadjuvant short course IMRT and IORT in people with Pancreatic Neoplasms, run by University Hospital Heidelberg at 3 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 10 inclusion and 21 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 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Falk FF Roeder, MD (+4962215639587, Falk.Roeder@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local recurrence rate (time frame: 1 year). 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 NCT01372735, 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 14 Jun 2011.

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