High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 13-008354
    • La Crosse, Wisconsin: 13-008354
    NCT ID: NCT01921751
    Sponsor Protocol Number: RTOG 1201

About this study

This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy in different ways and adding chemotherapy may kill more tumor cells. It is not yet known whether standard systemic chemotherapy followed by standard radiochemotherapy is more effective than standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy in treating pancreatic cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas within 45 days prior to registration
  • Tumor diameter ≤ 7 cm
  • Unresectable by radiographic criteria (pancreas protocol computed tomography [CT] or magnetic resonance imaging [MRI]) or exploration within 30 days prior to registration
  • A cell block or core biopsy must be submitted for central review and analysis of SMAD4 status as soon as possible following registration
  • No distant metastases, based upon the following minimum diagnostic workup:
    • History/physical examination within 30 days prior to registration
    • Whole body fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/CT within 30 days prior to registration
      • NOTE: If whole-body FDG-PET/CT is not performed, CT of the chest and CT (or MRI) of abdomen and pelvis must be obtained (imaging of abdomen and pelvis need not be repeated if already included in pancreas protocol study)
  • Zubrod performance status 0-1 within 30 days prior to registration
  • 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 hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)
  • Cancer antigen 19-9 (CA19-9); NOTE: in the event that a stent has been placed and biliary obstruction has been relieved, the CA19-9 should be drawn post stent placement
  • Creatinine < 2 mg/dl
  • Bilirubin < 2 mg/dl - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
  • Patient must provide study specific informed consent prior to study entry
  • Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment
  • For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration

Exclusion Criteria:

  • More than one primary lesion
  • Prior invasive malignancy (unless disease free for a minimum of 1095 days [3 years]); non-melanomatous skin cancer and previous early prostate cancer that had a non-rising prostate-specific antigen (PSA) are eligible
  • Prior systemic anti-cancer therapy for pancreatic cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields
  • 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 the last 6 months
    • 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
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
  • Pregnancy or women of childbearing potential, women who cannot discontinue breastfeeding and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the study drug(s) involved in this protocol
  • Pre-existing grade 2 or greater neuropathy
  • Distant metastases

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Haddock, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

La Crosse, Wis.

Mayo Clinic principal investigator

Michael Haddock, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

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CLS-20111744

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