Magnetic Resonance (MR) Guided, Dose-Escalated Radiation Therapy (RT) + Chemotherapy in Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT01972919 |
Recruitment Status :
Recruiting
First Posted : October 31, 2013
Last Update Posted : September 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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Unresectable Pancreatic Cancer | Radiation: Radiation Therapy Drug: Concurrent chemotherapy (Gemcitabine, Capecitabine) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 23 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-metastatic Pancreatic Cancer |
Actual Study Start Date : | December 10, 2015 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | May 2024 |

Arm | Intervention/treatment |
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Experimental: Radiation therapy plus chemotherapy
MR 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.
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Radiation: 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.
Other Name: Dose escalation radiation therapy Drug: Concurrent chemotherapy (Gemcitabine, Capecitabine) 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.
Other Names:
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- Efficacy of dose escalation [ Time Frame: Baseline and 1 year ]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.
- Radiographic response [ Time Frame: Baseline and 1 year ]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.
- Serum Cancer Antigen 19-9 (CA19-9) [ Time Frame: Baseline and 1 year ]This measure will be the mean serum activity of CA19-9 in units/mL.
- Serum Carcinoembryonic Antigen (CEA) [ Time Frame: Baseline and 1 year ]This measure will be the mean serum concentration of CEA in ng/mL.
- Radiation induced toxicity [ Time Frame: 3 months post treatment ]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.
- SMAD 4 expression [ Time Frame: 4 years ]This measure will be the number of participants whose tumor biopsy is positive for the presence of SMAD 4 protein.
- Overall Survival [ Time Frame: 1 and 2 years ]This measure will be the number of subjects alive at one and two years following the end of radiation treatment.
- Progression Free Survival [ Time Frame: 1 and 2 years ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
Exclusion criteria:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972919
Contact: Cancer Center Clinical Trials Office | 1-800-680-0505 ext 8900 | cccto@mcw.edu |
United States, Wisconsin | |
Froedtert Hospital | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Beth Erickson, MD 414-805-4460 berickson@mcw.edu | |
Contact 1-866-680-0505 ext 8900 cccto@mcw.edu | |
Principal Investigator: Beth Erickson, MD |
Principal Investigator: | Beth Erickson, MD | Froedtert & The Medical College of Wisconsin |
Responsible Party: | Beth Erickson, Professor, Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT01972919 |
Other Study ID Numbers: |
17687 |
First Posted: | October 31, 2013 Key Record Dates |
Last Update Posted: | September 2, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Pancreatic cancer |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |