AzTrials
AzTrials

Unresectable Pancreatic CancerPhase 2NCT01972919

MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer

A Phase 2 study testing Radiation Therapy and Concurrent chemotherapy (Gemcitabine, Capecitabine) in people with Unresectable Pancreatic Cancer, run by Medical College of Wisconsin at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Pancreatic Cancer
What is being tested?
Radiation Therapy and Concurrent chemotherapy (Gemcitabine, Capecitabine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
10 Dec 2015to 11 Jun 2026
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

  • Pathologically confirmed (histologic or cytologic), locally advanced, adenocarcinoma of the pancreas; patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability.
  • Participants with and without regional adenopathy are eligible.
  • No distant metastases, based upon the following minimum diagnostic workup:
  • History/physical examination, including collection of weight and vital signs, within 28 days prior to study entry;
  • Abdominal/pelvic CT scan with IV contrast within 21 days prior to study entry;
  • Chest CT scan, or X-ray within 21 days prior to study entry.
Show all 23Show fewer
  • Abdominal/pelvic MR prior to radiation with perfusion and diffusion- weighted sequences and MR and CT sim for radiation planning Pet scan within 21 days prior to study entry, Functional renal study.
  • Zubrod performance status 0-1 within 1 week of study entry.
  • Age ≥ 18.
  • Hematology and cancer antigen (CA) 19-9 / carcinoembryonic antigen (CEA) within 14 days prior to study entry, as follows.
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3;
  • Platelets ≥ 100,000 cells/mm^3;
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
  • Serum creatinine ≤ 1.5 mg/dl;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN);
  • Total bilirubin < 3.0 mg/dL;
  • Alkaline phosphatase < 3 x ULN;
  • Fasting blood glucose < 160 mg/dl.
  • Negative serum pregnancy test (if applicable) within 14 days prior to study entry.
  • Ability to swallow oral medications.
  • Participants must have had at least 4 months of prior systemic chemotherapy.
  • Participants must provide study specific informed consent prior to study entry.
  • Women of childbearing potential and male participants who are sexually active must practice adequate contraception.

Who cannot join

  • Distant metastatic disease, second malignancy or peritoneal seeding;
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Any major surgery within 28 days prior to study entry
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
Show all 18Show fewer
  • Transmural myocardial infarction within 3 months prior to study entry;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration;
  • Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function;
  • Any unresolved bowel or bile duct obstruction;
  • Major resection of the stomach or small bowel that could affect the absorption of capecitabine
  • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition;
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women, for 3 months after the last study drug administration.
  • Women who are lactating at the time of registration and who plan to be lactating through 3 months after the last study drug administration.
  • Prior allergic reaction to capecitabine or gemcitabine
  • Inability to undergo an MR of the abdomen/pelvis
  • Participation in another clinical treatment trial while on study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-metastatic Pancreatic Cancer

This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this chemotherapy course.

Read the detailed description

In this study the investigators want to find out more about the efficacy of giving higher doses of radiation with concurrent chemotherapy in controlling unresectable pancreas cancers than are used in either the pre-operative or post-operative setting. The investigators will assess acute and late side effects (problems and symptoms) of radiation therapy given at these higher doses of radiation (dose escalated) following full dose chemotherapy given before the radiation and with concurrent chemotherapy for pancreas cancer. Radiation therapy is given in higher doses that are limited by the proximity of normal organs to the radiation dose distribution to improve the likelihood of controlling the tumor in the pancreas while minimizing the risk of radiation injury to these organs. There are two chemotherapy drugs, Capecitabine is an oral drug taken twice per day on the same day that radiation therapy is given and Gemcitabine is an intravenous drug given once per week, during radiation therapy. Everyone in this study will have already received chemotherapy alone first. Everyone in this study will receive radiation therapy and concurrent chemotherapy.

Being tested
Radiation Therapy, Concurrent chemotherapy (Gemcitabine, Capecitabine)
Keywords
Pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Radiation TherapyRadiation

    Also called Dose escalation radiation therapy

    Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction.

  • Concurrent chemotherapy (Gemcitabine, Capecitabine)Drug

    Also called Gemzar, Xeloda

    Gemcitabine 400mg/m^2 IV weekly x 6 doses. Capecitabine 825 mg/m^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.

Study groups in NCT01972919
Study groupRoleWhat they receive
Radiation therapy plus chemotherapyExperimentalMR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine.
Receives: Radiation: Radiation Therapy; Drug: Concurrent chemotherapy (Gemcitabine, Capecitabine)

What is being measured

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

  1. Overall Survival

    This measure will be the number of subjects alive at one and two years following the end of radiation treatment, up to two years and seven weeks.

    Measured: 1 and 2 years following up to 7 weeks of radiation treatment

Secondary outcomes (7)

  1. Radiographic Response

    Number of participants treated with the proposed dose escalation achieving CR, PR, or SD measured by RECIST 1.1 criteria from magnetic resonance imaging (MRI), positron emission tomography (PET) or computed tomography (SC) scans.

    Measured: Baseline and 1 year

  2. Serum Cancer Antigen 19-9 (CA19-9)

    This measure will be the mean serum activity of CA19-9 in units/mL.

    Measured: Baseline and 1 year

  3. Serum Carcinoembryonic Antigen (CEA)

    This measure will be the mean serum concentration of CEA in ng/mL.

    Measured: Baseline and 1 year

  4. Radiation Induced Toxicity

    This measure will be the number of subjects experiencing a serious adverse event or grade three or higher non-serious adverse event by CTCAE v4.03 criteria that is definitely, likely, or possibly attributable to the radiation therapy.

    Measured: 3 months post treatment

  5. SMAD 4 Expression

    This measure will be the number of participants whose tumor biopsy is positive for the presence of SMAD 4 protein.

    Measured: Baseline

  6. Progression Free Survival

    This measure will be the number of subjects achieving a CR or PR or maintaining SD by RECIST 1.1 criteria one and two years following the end of radiation treatment.

    Measured: 1 and 2 years

  7. Efficacy of Dose Escalation

    This measure is the change from baseline of gross tumor volume for participants achieving a complete response (CR) or partial response (PR) or maintaining stable disease (SD) by RECIST 1.1 criteria.

    Measured: Baseline and 1 year

Timeline

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

  1. First posted31 Oct 2013 (estimated)
  2. Study start10 Dec 2015
  3. Primary completion13 Dec 2023
  4. Study completion11 Jun 2026

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01972919
Sponsor's protocol ID
17687
Status last verified
Aug 2026
First submitted
29 Aug 2013
Last updated
4 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy and Concurrent chemotherapy (Gemcitabine, Capecitabine) in people with Unresectable Pancreatic Cancer, run by Medical College of Wisconsin 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 23 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: finished, as of the sponsor's last update on 4 Sep 2026. 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 10 Feb 2025). 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?

Overall Survival (time frame: 1 and 2 years following up to 7 weeks of radiation treatment). 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 NCT01972919.

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 4 Sep 2026.

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