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Pancreatic AdenocarcinomaPhase 2NCT01726582

Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery ("Personalized Medicine")

A Phase 2 study testing Milestone 1: Targeted chemotherapy prior to surgery, Milestone 2: Chemoradiotherapy (cXRT) and Milestone 3: Targeted chemotherapy prior to surgery in people with Pancreatic Adenocarcinoma, run by Medical College of Wisconsin at 2 sites in United States.

Completed

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

Official record
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Trial summary

In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular profiling). 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?
Milestone 1: Targeted chemotherapy prior to surgery, Milestone 2: Chemoradiotherapy (cXRT) and Milestone 3: Targeted chemotherapy prior to surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
2 sitesUnited States
Study dates
Nov 2011to 11 Apr 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Able to understand and provide written informed consent
  • Diagnosis of adenocarcinoma of the pancreas or high suspicion of adenocarcinoma of the pancreas based on CT and MRI findings as detailed below by "Definition of...."
  • Treatment Eligibility Criteria:
  • Have an Eastern Cooperative Oncology Group performance status less than or equal to 2
  • Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas
Show all 29Show fewer
  • Have adequate organ and bone marrow function as defined by:
  • total leukocytes greater than or equal to 3 x1000/μL
  • absolute neutrophil count (ANC) > or equal to 1.5x 1000/μL
  • hemoglobin > or equal to 9 g/dL
  • platelets > or equal to 100 x 1000/μL
  • creatinine clearance >60 mL/min or creatinine < or equal to 1.5 mg/dL
  • bilirubin < or equal to 2 mg/dL or >2 and declining as described in the protocol
  • aspartate transaminases (AST/SGOT) < or equal to3 x upper limit of normal (ULN)
  • alanine transaminases (ALT/SGPT) < or equal to 3 x ULN
  • Female patients must be post menopausal for > 1 year, surgically sterile, or have a negative pregnancy test and used at least one form of contraception for 4 weeks prior to Day 1 of the study, during study treatment and during the first 4 months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for 4 months after the last dose of any study drug.
  • Definition of Resectable Pancreatic Cancer includes:
  • No evidence of extra-pancreatic disease
  • No evidence of tumor-arterial abutment (celiac, superior mesenteric artery or hepatic artery)
  • If tumor induced narrowing of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence is present it must be <50% of the diameter of the vessel
  • Ca19-9 <5000, when bilirubin is <2 (or >2 and declining as described in the protocol)
  • Definition of Borderline Resectable Pancreatic Cancer to include at least one of the following:
  • Tumor abutment < or equal to 180 degrees of the superior mesenteric artery or celiac axis
  • Tumor abutment or encasement (>180 degrees) of a short segment of the hepatic artery
  • Tumor induced narrowing of superior mesenteric vein, portal vein or superior mesenteric-portal vein of >50% of the diameter of the vessel.
  • Short segment occlusion of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence with a suitable portal vein above and superior mesenteric vein below, for reconstruction
  • CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment at the Medical College of Wisconsin weekly pancreatic cancer conference)
  • Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound-guided fine needle aspirate
  • Resectable tumor and cancer antigen 19-9 (CA19-9) >5000

Who cannot join

  • Any patient with one or more of the following will be excluded:
  • Have received chemotherapy or chemoradiation within 5 years prior of study enrollment
  • Have any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study enrollment
  • Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
  • Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection
  • Pregnant or breast-feeding patients or any patient with child-bearing potential not using contraception 4 weeks prior to, during and 4 months after study treatment is discontinued

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45221

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas

In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy and radiation therapy) that the patient will receive before having surgery to remove the adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is tested again. The results of that test are used to guide the choice of therapy after surgery.

The chemotherapy drugs and the radiation therapy used in this clinical trial are already approved for treatment of pancreas cancer. This trial is intended to establish which treatment is best for a specific patient, based on test results from that patient's actual adenocarcinoma. In the past, the decision as to which treatment the patient will receive was not based on testing of the actual adenocarcinoma.

Read more

See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm.

Hypothesis: Resectability rate, overall survival rate and progression-free survival in subjects with adenocarcinoma of the pancreas will be superior for who receive targeted "personalized" therapy.

Being tested
Milestone 1: Targeted chemotherapy prior to surgery, Milestone 2: Chemoradiotherapy (cXRT), Milestone 3: Targeted chemotherapy prior to surgery, Milestone 3: Chemoradiotherapy (cXRT), Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery
Keywords
pancreas, adenocarcinoma, molecular profile, molecular profiling, pancreatic cancer, pancreas cancer, cancer, molecular target, pancreas head, pancreas neck, pancreas uncinate, pancreas body, pancreas tail
Medical subject headings
Adenocarcinoma, Pancreatic Neoplasms, Neoplasms

What participants receive

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

  • Milestone 1: Targeted chemotherapy prior to surgeryDrug

    Also called FOLFIRINOX, FOLFIRI, Gemcitabine with irinotecan, Gemcitabine / oxaliplatin

    The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.

  • Milestone 2: Chemoradiotherapy (cXRT)Radiation

    Also called Gemcitabine, Capecitabine

    A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or intensity-modulated radiation therapy (IMRT) techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

  • Milestone 3: Targeted chemotherapy prior to surgeryDrug

    Also called FOLFIRINOX, FOLFIRI, Gemcitabine with irinotecan, Gemcitabine / oxaliplatin

    The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.

  • Milestone 3: Chemoradiotherapy (cXRT)Radiation

    Also called Gemcitabine, Capecitabine

    A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

  • Milestone 4: standard FOLFIRINOX chemotherapy prior to surgeryDrug

    Also called FOLFIRINOX, oxaliplatin, irinotecan, leucovorin

    A biopsy of the borderline tumor does not provide a molecular profile that can be used to target treatment. The treatment will be standard FOLFIRINOX chemotherapy regimen.

  • Milestone 4: Chemoradiotherapy (cXRT)Radiation

    Also called Gemcitabine, Capecitabine

    A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

  • Milestone 5: Targeted chemotherapy after surgeryDrug

    Also called FOLFIRINOX, FOLFIRI, Gemcitabine with irinotecan, Gemcitabine / oxaliplatin

    The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.

  • Milestone 5: Chemoradiotherapy (cXRT)Radiation

    Also called Gemcitabine, Capecitabine

    A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

  • Milestone 6: Gemcitabine after surgeryDrug

    Also called Chemotherapy treatment with Gemcitabine., Gemzar

    Chemotherapy treatment with Gemcitabine.

  • Milestone 6: Chemoradiotherapy (cXRT)Radiation

    Also called Gemcitabine, Capecitabine

    A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

  • Milestone 7: Chemoradiotherapy (cXRT)Radiation

    Also called Gemcitabine, Capecitabine

    A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

  • Milestone 8: Targeted chemotherapy after surgeryDrug

    Also called FOLFIRINOX, FOLFIRI, Gemcitabine with irinotecan, Gemcitabine / oxaliplatin

    The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.

  • Milestone 9: Gemcitabine after surgeryDrug

    Also called Gemzar

    Chemotherapy treatment with Gemcitabine.

  • Milestone 10: No additional therapy after surgeryOther

    Also called Restaged after surgery. No additional therapy.

    The molecular profile of the tumor that was removed during surgery points to a lack of treatment affect for available therapies. No additional therapy is recommended.

Study groups in NCT01726582
Study groupRoleWhat they receive
Milestones related to therapyExperimentalMilestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging. Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging. Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging. Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging. Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging. Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging. Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
Receives: Drug: Milestone 1: Targeted chemotherapy prior to surgery; Radiation: Milestone 2: Chemoradiotherapy (cXRT); Drug: Milestone 3: Targeted chemotherapy prior to surgery; Radiation: Milestone 3: Chemoradiotherapy (cXRT); Drug: Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery; Radiation: Milestone 4: Chemoradiotherapy (cXRT); Drug: Milestone 5: Targeted chemotherapy after surgery; Radiation: Milestone 5: Chemoradiotherapy (cXRT); Drug: Milestone 6: Gemcitabine after surgery; Radiation: Milestone 6: Chemoradiotherapy (cXRT); Radiation: Milestone 7: Chemoradiotherapy (cXRT); Drug: Milestone 8: Targeted chemotherapy after surgery; Drug: Milestone 9: Gemcitabine after surgery; Other: Milestone 10: No additional therapy after surgery

What is being measured

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

  1. Number of Subjects Completing Therapy Including Surgical Resection.

    This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.

    Measured: At time of surgery (approximately 10 to 20 weeks after screening)

Secondary outcomes (4)

  1. Overall Survival in Months

    This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.

    Measured: 5 years

  2. Progression-free Survival

    This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.

    Measured: 5 years

  3. Use of Biomarkers to Determine Course of Treatment

    The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.

    Measured: Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)

  4. Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.

    The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).

    Measured: At time of surgery (approximately 10 to 20 weeks after screening)

Timeline

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

  1. First posted15 Nov 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionJun 2018
  4. Study completion11 Apr 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01726582
Sponsor's protocol ID
MCW 15565
Other IDs
Advancing a Healthier WI, FP 7718
Status last verified
Jul 2023
First submitted
28 Dec 2011
Last updated
14 Aug 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.

    PubMed 20180029

  • Tsai S, Christians KK, George B, Ritch PS, Dua K, Khan A, Mackinnon AC, Tolat P, Ahmad SA, Hall WA, Erickson BA, Evans DB. A Phase II Clinical Trial of Molecular Profiled Neoadjuvant Therapy for Localized Pancreatic Ductal Adenocarcinoma. Ann Surg. 2018 Oct;268(4):610-619. doi: 10.1097/SLA.0000000000002957.

    PubMed 30080723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Milestone 1: Targeted chemotherapy prior to surgery, Milestone 2: Chemoradiotherapy (cXRT) and Milestone 3: Targeted chemotherapy prior to surgery in people with Pancreatic Adenocarcinoma, run by Medical College of Wisconsin at 2 sites 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 29 inclusion and 6 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 14 Aug 2023). 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?

Number of Subjects Completing Therapy Including Surgical Resection. (time frame: At time of surgery (approximately 10 to 20 weeks after screening)). 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 NCT01726582, 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 14 Aug 2023.

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