Ductal Adenocarcinoma of PancreasPhase 2NCT02626520
Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla
A Phase 2 study testing Gemcitabine and nanoparticle albumin bound paclitaxel, 5-fluorouracil and irinotecan and Preoperative chemoradiation in people with Ductal Adenocarcinoma of Pancreas and Adenocarcinoma of Ampulla, run by Essentia Health at 1 site in United States.
Trial summary
Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ductal Adenocarcinoma of Pancreas, Adenocarcinoma of Ampulla
- What is being tested?
- Gemcitabine and nanoparticle albumin bound paclitaxel, 5-fluorouracil and irinotecan and Preoperative chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2016to 14 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
- Fitness for chemotherapy in judgement of treating physician
- Bilirubin < 4 (any means of biliary drainage acceptable)
Who cannot join
- Medical or mental illness precluding provision of informed consent
- Pregnancy
- Active infection for which neutropenia would pose high risk of mortality
Trial locations and contacts
1 site in 1 country.
United States1 site
Essentia Health Cancer Center
Duluth, Minnesota, 55805
About this study
Official title: Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla
Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.
Read the detailed description
Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).
All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.
All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.
Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.
Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.
- Being tested
- Gemcitabine and nanoparticle albumin bound paclitaxel, 5-fluorouracil and irinotecan, Preoperative chemoradiation, Definitive resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine and nanoparticle albumin bound paclitaxelDrug
Also called Gem/Abraxane, Gemcitabine/nab-paclitaxel
Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles
5-fluorouracil and irinotecanDrug
Also called FOLFIRI.3, FOLFIRI-3
FOLFIRI.3 given every 14 days x 4 cycles
Preoperative chemoradiationRadiation
Pre-operative chemoradiation to 40 Gy in 20 fractions
Definitive resectionProcedure or surgery
Also called pancreaticoduodenectomy, Whipple procedure
Definitive surgical resection of primary tumor
| Study group | Role | What they receive |
|---|---|---|
| Resectable, Low Risk | Experimental | Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Receives: Drug: Gemcitabine and nanoparticle albumin bound paclitaxel; Procedure: Definitive resection |
| Locally Advanced | Experimental | Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Receives: Drug: Gemcitabine and nanoparticle albumin bound paclitaxel; Drug: 5-fluorouracil and irinotecan; Radiation: Preoperative chemoradiation; Procedure: Definitive resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival
Percentage of patients alive and free of detectable disease 1 yr from start of treatment
Measured: 1 yr form onset of treatment
Secondary outcomes (2)
R-0 Rate
Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)
Measured: Time of surgery
Overall Survival
Time to death from any cause measured from start of treatment
Measured: Up to 3 years from registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start11 May 2016
- Primary completion20 Sep 2016
- Study completion14 Sep 2017
Why it stopped: Study team felt toxicity of study regimen outweighed potential benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ductal Adenocarcinoma of PancreasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kebbekus, MD, PhD, Principal investigator, Essentia Health Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626520
- Sponsor's protocol ID
- PANC-1
- Status last verified
- Oct 2018
- First submitted
- 3 Dec 2015
- Last updated
- 13 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will make unidentified dataset available for electronic download.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla
- ClinicalTrials.gov ID
- NCT02626520
- Acronym / sponsor ID
- PANC-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team felt toxicity of study regimen outweighed potential benefit.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.
Detailed description
Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).
All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.
All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.
Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.
Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resectable, Low Risk | Experimental | Drug: Gemcitabine and nanoparticle albumin bound paclitaxel, Procedure: Definitive resectionSystemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. |
| Locally Advanced | Experimental | Drug: Gemcitabine and nanoparticle albumin bound paclitaxel, Drug: 5-fluorouracil and irinotecan, Radiation: Preoperative chemoradiation, Procedure: Definitive resectionSystemic chemotherapy followed by chemoradiation, followed by definitive surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
- Fitness for chemotherapy in judgement of treating physician
- Bilirubin < 4 (any means of biliary drainage acceptable)
Key exclusion criteria (3 listed)
- Medical or mental illness precluding provision of informed consent
- Pregnancy
- Active infection for which neutropenia would pose high risk of mortality
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 |
|---|---|---|
| Gemcitabine and nanoparticle albumin bound paclitaxelAlso: Gem/Abraxane, Gemcitabine/nab-paclitaxelGemcitabine and nab-paclitaxel given every 14 days x 4 cycles | Drug | Locally Advanced, Resectable, Low Risk |
| 5-fluorouracil and irinotecanAlso: FOLFIRI.3, FOLFIRI-3FOLFIRI.3 given every 14 days x 4 cycles | Drug | Locally Advanced |
| Preoperative chemoradiationPre-operative chemoradiation to 40 Gy in 20 fractions | Radiation | Locally Advanced |
| Definitive resectionAlso: pancreaticoduodenectomy, Whipple procedureDefinitive surgical resection of primary tumor | Procedure or surgery | Locally Advanced, Resectable, Low Risk |
Primary outcome
Relapse Free Survival
Time frame: 1 yr form onset of treatment
Percentage of patients alive and free of detectable disease 1 yr from start of treatment
2 secondary outcomes
R-0 Rate
Time frame: Time of surgery
Overall Survival
Time frame: Up to 3 years from registration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will make unidentified dataset available for electronic download.
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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.
Peter Kebbekus, MD, PhD principal investigator
Essentia Health Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and nanoparticle albumin bound paclitaxel, 5-fluorouracil and irinotecan and Preoperative chemoradiation in people with Ductal Adenocarcinoma of Pancreas and Adenocarcinoma of Ampulla, run by Essentia Health at 1 site in United States.
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 3 inclusion and 3 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 13 Nov 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relapse Free Survival (time frame: 1 yr form onset of treatment). 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 13 Nov 2018.