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Magnetic Resonance (MR) Guided, Dose-Escalated Radiation Therapy (RT) + Chemotherapy in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01972919
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Beth Erickson, Medical College of Wisconsin

Brief 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 chemotherapy course.

Condition or disease Intervention/treatment Phase
Unresectable Pancreatic Cancer Radiation: Radiation Therapy Drug: Concurrent chemotherapy (Gemcitabine, Capecitabine) Phase 2

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.

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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 : December 2020
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
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.
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/m2 IV weekly x 6 doses. Capecitabine 825 mg/m^2 by mouth twice daily Monday-Friday on days of radiation use 500mg tablets.
Other Names:
  • Gemcitabine
  • Capecitabine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Serum Carcinoembryonic Antigen (CEA) [ Time Frame: Baseline and 1 year ]
    This measure will be the mean serum concentration of CEA in ng/mL.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Cancer Center Clinical Trials Office 1-800-680-0505 ext 8900 cccto@mcw.edu

Locations
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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         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Beth Erickson, MD Froedtert & The Medical College of Wisconsin
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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: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Beth Erickson, Medical College of Wisconsin:
Pancreatic cancer
Cancer
Additional relevant MeSH terms:
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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