Pancreatic AdenocarcinomaPhase 3Net-PacNCT01419002
Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer
A Phase 3 study testing neoadjuvant RTx and Surgery in people with Pancreatic Adenocarcinoma, run by CHIR-Net at 1 site in Germany.
Trial summary
Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- neoadjuvant RTx and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Oct 2014
- 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
- Histologically confirmed adenocarcinoma of the pancreatic head
- Age ≥ 18 years
- Signed informed consent
- ECOG performance status of 0-2
Who cannot join
- Curative resection is not feasible or presence of metastatic disease
- Patients not eligible for surgery (ASA ≥ 4)
- Participation in an other clinical trial
- Unable or unwilling to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar, Technische Universität München
Munich, 81675
About this study
Official title: Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial
Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.
Read the detailed description
The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- neoadjuvant RTx, Surgery
- Keywords
- Pancreatic Cancer, Adenocarcinoma, Neoadjuvant Radiotherapy
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant RTxRadiation
Also called Intensity modulated beam radiation (IMBR).
Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.
SurgeryProcedure or surgery
Also called Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple
Surgery and adjuvant chemotherapy according to German S3-guidelines
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant RTx | Experimental | Not described Receives: Radiation: neoadjuvant RTx |
| Surgery | Active comparator | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence free survival
Measured: At 12 months postoperative
Secondary outcomes (7)
Percentage of surgical R0-resections in both groups
Determined by histopathological analysis of the surgical specimen.
Measured: Until 10 days postoperative
30-day morbidity and mortality
Measured: 30 day period after the operation
Toxicity of preoperative Radiotherapy
Number of patients with adverse events in both groups, number of adverse events in both groups and number of grade 3 and 4 adverse events according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) in both groups
Measured: Start of the radiotherapy until 12 months postoperative.
Clinical response rate (RECIST-criteria) and histological response rate
Measured: Until 1 year postOP
Time to tumor progression (local and systemic)
Measured: Until 1 year postoperative
Quality of life
Measured: Until 12 months postoperative
Overall survival after 1 year
Measured: Until 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: lack of recruitment
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHIR-Net
- Sponsor type
- Research network
- Collaborators
- Technical University of Munich
- Responsible party
- Sponsor
- Investigators
- Helmut M Friess, Prof. MD, Principal investigator, Technical University of MunichMichael Molls, Prof. MD, Study director, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419002
- Sponsor's protocol ID
- NetPac
- Acronym
- Net-Pac
- Status last verified
- Jul 2015
- First submitted
- 13 Aug 2011
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT01419002
- Acronym / sponsor ID
- Net-Pac / NetPac
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic Cancer, Adenocarcinoma, Neoadjuvant Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CHIR-NetResearch network
- Collaborators
- Technical University of Munich
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Aug 2011 (estimated)
- 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.
Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.
Detailed description
The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant RTx | Experimental | Radiation: neoadjuvant RTx |
| Surgery | Active comparator | Procedure: Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed adenocarcinoma of the pancreatic head
- Age ≥ 18 years
- Signed informed consent
- ECOG performance status of 0-2
Key exclusion criteria (4 listed)
- Curative resection is not feasible or presence of metastatic disease
- Patients not eligible for surgery (ASA ≥ 4)
- Participation in an other clinical trial
- Unable or unwilling to sign the informed consent
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 |
|---|---|---|
| neoadjuvant RTxAlso: Intensity modulated beam radiation (IMBR).Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines. | Radiation | Neoadjuvant RTx |
| SurgeryAlso: Kausch-Whipple, Pancreaticoduodenectomy, ppWhippleSurgery and adjuvant chemotherapy according to German S3-guidelines | Procedure or surgery | Surgery |
Primary outcome
Local recurrence free survival
Time frame: At 12 months postoperative
7 secondary outcomes
Percentage of surgical R0-resections in both groups
Time frame: Until 10 days postoperative
30-day morbidity and mortality
Time frame: 30 day period after the operation
Toxicity of preoperative Radiotherapy
Time frame: Start of the radiotherapy until 12 months postoperative.
Clinical response rate (RECIST-criteria) and histological response rate
Time frame: Until 1 year postOP
Time to tumor progression (local and systemic)
Time frame: Until 1 year postoperative
Quality of life
Time frame: Until 12 months postoperative
Overall survival after 1 year
Time frame: Until 1 year postoperative
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Department of Radiation Oncology, Technische Universität MünchenLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Helmut M Friess, Prof. MD principal investigator
Technical University of Munich
Michael Molls, Prof. MD study director
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neoadjuvant RTx and Surgery in people with Pancreatic Adenocarcinoma, run by CHIR-Net 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 4 inclusion and 4 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 29 Jul 2015. 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 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: lack of recruitment). 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?
Local recurrence free survival (time frame: At 12 months postoperative). 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 29 Jul 2015.