Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03704662
Previous Study | Return to List | Next Study

Stereotactic Body Radiation Therapy or Conventionally Fractionated Concurrent Chemotherapy and Radiation Therapy Preoperatively for Resectable or Borderline Resectable Pancreatic Adenocarcinoma

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: NCT03704662
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
William Hall, Medical College of Wisconsin

Brief Summary:
Patients are randomized into two arms. Arm A patients will receive Stereotactic Body Radiation Therapy (SBRT) and Arm B patients with receive conventional concurrent chemotherapy and radiation therapy.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Stereotactic Body Radiation Therapy Radiation: Preoperative Fractionated Radiation Therapy and Chemotherapy Not Applicable

Detailed Description:

RATIONALE: There are limited studies comparing novel radiation treatments with stereotactic body radiation therapy (SBRT) in pancreatic adenocarcinoma to conventional fractionation. Much of the existing literature indicates this technique is safe and convenient for patients, as compared with conventionally fractionated concurrent chemo-radiation therapy. However, there has been no direct comparison of these two treatment modalities when given in the preoperative setting. It also remains uncertain if SBRT results in similar nodal downstaging to preoperative, conventionally fractionated chemo-RT.

STUDY DESIGN: This study is a prospective, open-label, randomized, parallel, two-arm, phase II clinical trial. Patients meeting the eligibility criteria will be randomized after a minimum of two months of induction chemotherapy. These patients will be required to have no biopsy-proven distant disease on repeat staging studies before randomization. Patients who have radiologically equivocal evidence of distant metastatic disease (small lung nodules, or liver lesions that cannot be definitively characterized, etc.) are also eligible for enrollment. Patients with biopsy-proven metastatic disease are not eligible. The total number of patients planned for accrual is approximately 102 patients (51 patients per arm).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation Therapy or Conventionally Fractionated Concurrent Chemotherapy and Radiation Therapy Preoperatively for Resectable or Borderline Resectable Pancreatic Adenocarcinoma
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Stereotactic Body Radiation Therapy
Patients undergo Stereotactic Body Radiation Therapy (SBRT) five days a week for 1.5 weeks.
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Name: SBRT

Preoperative Fractionated Radiation Therapy and Chemotherapy
Patients undergo Fractionated Radiation Therapy five days a week for 5.5 weeks, followed by a chemotherapy regimen.
Radiation: Preoperative Fractionated Radiation Therapy and Chemotherapy
Conventional concurrent chemotherapy and radiation therapy.




Primary Outcome Measures :
  1. Percentage of patients with node-positive disease following surgical resection comparison of conventially fractionated chemo RT versus SBRT. [ Time Frame: up to six months. ]
    We will use a two-sided exact binomial test of proportions to compare the rates of node positivity between the conventional therapy versus the SBRT groups.


Secondary Outcome Measures :
  1. Compare patient-reported quality of life, as measured by the pancreatic cancer-specific QLQ PAN26 questionnaire. [ Time Frame: up to six months after surgery. ]
    Quality-of-life assessments will be compared between groups, using a two-sided t-test.

  2. Overall survival. [ Time Frame: Up to 5 years ]
    We will use the Kaplan-Meier method to estimate this. This will be compared between arms, using the log-rank test.

  3. Progression-free survival. [ Time Frame: Up to 5 years. ]
    We will use the Kaplan-Meier method to estimate this. This will be compared between arms, using the log-rank test.

  4. Compare the proportions of toxic effects between the treatment arms. [ Time Frame: Up to 2 years. ]
    We will tabulate the toxicity data by grading it as absent or present at grades 1-4 (NCI CTCAE Version 4 criteria) and compare the scores for both the conventionally fractionated and the SBRT arms, using a chi-squared test.

  5. Compare surgical complications. [ Time Frame: Assessed at time of surgery and up to six weeks following. ]
    This will be measured by the measured by the Clavien-Dindo Complications Score, unexpected surgical complications and blood loss. The scale has 5 grades with 2 further subdivided. Grade 1: Any deviation from the normal postoperative course w/o the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade 2: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutrition included. Grade 3: Requiring surgical, endoscopic or radiological intervention. Grade 3a: Intervention not under general anesthesia. Grade 3b: Intervention under general anesthesia. Grade 4: Life-threatening complication (including CNS complications) requiring IC/ICU-management. Grade 4a: single organ dysfunction (including dialysis). Grade 4b: multiorgandysfunction. Grade 5: Death.



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.


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

Inclusion Criteria:

  1. Pathologically confirmed (histologic or cytological), resectable, borderline resectable, or locally advanced type A adenocarcinoma of the pancreas; patients must have resectable, borderline resectable, or locally advanced type A disease, based on institutional standardized criteria and tumor board review.
  2. Patients with and without regional adenopathy are eligible.
  3. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise. Any biopsy-proven metastatic disease will make the patient ineligible for study participation.
  4. History/physical examination, including collection of weight and vital signs, within 30 days prior to start of treatment.
  5. Diagnostic abdominal/pelvic CT with IV contrast or abdominopelvic MR scan with perfusion and diffusion-weighted sequences within 30 days prior to study entry.
  6. Chest CT scan or X-ray within 30 days prior to study entry.
  7. Radiation treatment planning abdominal CT. A recommended abdominal MR will be done as a SIM with interpretation. The CT SIM will not be done with interpretation. PET scan and MRI are both optional but encouraged. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is optional but encouraged.
  8. ECOG performance status 0-2 within 14 days of randomization.
  9. Age ≥ 18.
  10. Heme Onc (Chem 24) and CA 19-9/CEA within 30 days prior to treatment, as follows:

    • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
    • Platelets ≥100,000 cells/mm3 (see section 4)
    • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
    • ALT or AST < 4 x upper limit of normal
    • Total bilirubin < 1.5 x upper normal mg/dL
    • Alkaline phosphatase < 4 x upper limit of normal
  11. Not on hemodialysis.
  12. Negative serum pregnancy test (if applicable).
  13. Ability to swallow oral medications.
  14. Patients must have had at least two months of systemic chemotherapy without evidence of distant progression.
  15. Patient must provide study-specific informed consent prior to study entry.
  16. Women of childbearing potential and male participants who are sexually active must practice adequate contraception.

Exclusion Criteria:

  1. Distant metastatic disease.
  2. Prior invasive malignancy (except nonmelanomatous skin cancer), unless disease free for a minimum of three years (for example, carcinoma in situ of the breast, oral cavity or cervix are all permissible).
  3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  4. Any major surgery within 28 days prior to study entry (for example, insertion of a vascular access device or biliary stent, exploratory laparotomy and/or laparoscopy are not considered major surgery; biliary or gastric bypass is considered major surgery).
  5. Severe, active comorbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
    • Transmural myocardial infarction within three 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. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with capecitabine.
    • Absence of any significant medical comorbidity which would preclude the consideration of major pancreatic surgery.
  6. 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 three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  7. Women who are lactating at the time of registration and who plan to be lactating through three months after study therapy is completed.
  8. Prior allergic reaction to capecitabine or gemcitabine.
  9. Participation in another interventional clinical treatment trial while on study (observational trials are permitted).
  10. Patients taking nonprotocol-specified chemotherapy agents or immune modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI.

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): NCT03704662


Contacts
Layout table for location contacts
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu

Locations
Layout table for location information
United States, Wisconsin
Froedtert Hospital & Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office    414-805-8900    cccto@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Layout table for investigator information
Principal Investigator: William Hall, MD Medical College of Wisconsin

Layout table for additonal information
Responsible Party: William Hall, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03704662    
Other Study ID Numbers: PRO33061
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by William Hall, Medical College of Wisconsin:
resectable pancreatic adenocarcinoma
borderline resectable pancreatic adenocarcinoma
Stereotactic Body Radiation Therapy
Preoperative Fractionated Radiation Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms