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MR Guided Dose Escalated RT + Concurrent Chemotherapy in Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01972919
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : November 12, 2018
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
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
Study Start Date : March 2016
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 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 1m2 IV weekly x 6 doses. Capecitabine 825 mg/mm2 po bid Monday-Friday on days of radiation use 500mg tablets.
Other Names:
  • Gemcitabine
  • Capecitabine




Primary Outcome Measures :
  1. To evaluate the efficacy of dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction for unresectable pancreatic cancer. [ Time Frame: One year from the start of treatment ]
    To evaluate acute and late (> 3 months post treatment) radiation induced toxicities.


Secondary Outcome Measures :
  1. To evaluate radiographic and biochemical response for patients treated with the proposed dose escalation. [ Time Frame: One year from the start of treatment ]
    To evaluate radiographic and biochemical response for patients treated with the proposed dose escalation using pre- and post- treatment MR and PET scanning in addition to routine surveillance CT scans and CEA/ CA 19-9 levels.

  2. Radiation induced toxicities [ Time Frame: > 3 months post treatment ]
    To evaluate acute (> 3 months post treatment) and late radiation induced toxicities.

  3. SMAD 4 expression [ Time Frame: 4 years ]
    SMAD 4 expression vs pattern of relapse

  4. Survival rates [ Time Frame: 7 years ]
    1 & 2 year overall survival, median survival and progression survival rates.



Information from the National Library of Medicine

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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:

3.1 Conditions for Patient Eligibility

  • 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.
  • Patients 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.
  • Heme Onc and CA 19-9/CEA within 14 days prior to study entry, as follows.
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
  • Platelets ≥ 100,000 cells/mm3;
  • 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;
  • ALT or AST < 3 x upper limit of normal;
  • Total bilirubin < 3.0 mg/dL;
  • Alkaline phosphatase < 3 x upper limit of normal;
  • Fasting blood glucose < 160 mg/dl.
  • Negative serum pregnancy test (if applicable) within 14 days prior to study entry.
  • Ability to swallow oral medications.
  • Patients must have had at least 4 months of prior systemic chemotherapy.
  • Patient 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 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     History of Changes
Other Study ID Numbers: 17687
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System 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