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Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreas Cancer With Assessment of Treatment Response Utilizing Molecular Biomarkers

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ClinicalTrials.gov Identifier: NCT03902600
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Kenneth W. Merrell, Mayo Clinic

Study Description
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Brief Summary:
This study will observe side effects for patients who receive a 3-week course of radiation and chemotherapy for pancreas cancer. Blood samples will be collected before and after treatment to assess pancreas cancer DNA levels and its impact on outcomes.

Condition or disease Intervention/treatment
Pancreatic Cancer Radiation: Moderately Hypofractionated RT

Study Design
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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreas Cancer With Assessment of Treatment Response Utilizing Molecular Biomarkers
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Radiation: Moderately Hypofractionated RT
    Patients will be treated with moderately hypofractionated radiation treatment

Outcome Measures
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Primary Outcome Measures :
  1. Acute grade 3 or higher GI AEs [ Time Frame: 2 years after CRT ]
    acute grade 3 or higher GI AEs attributable to hypofractionated concurrent chemoradiotherapy (CRT)


Secondary Outcome Measures :
  1. late grade 3 or higher GI AEs [ Time Frame: 2 years after CRT ]
    ate grade 3 or higher GI AEs attributable to hypofractionated concurrent CRT

  2. local-regional recurrence [ Time Frame: 2 years after CRT ]
    local-regional recurrence

  3. progression free survival (PFS) [ Time Frame: 2 years after CRT ]
    progression free survival (PFS)

  4. overall survival [ Time Frame: 2 years after CRT or until death ]
    overall survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with pancreatic cancer
Criteria

Inclusion Criteria: -Age ≥ 18 years

  • Histological confirmation of adenocarcinoma of the pancreas (head, body, or tail of pancreas)
  • Imaging consistent with T1-4, N0-2, M0 pancreas cancer, including potentially resectable, boarderline resectable, or unresectable disease as per NCCN classification. When CT of the chest, abdomen, and pelvis are performed, this must be with contras per pancreas protocol. Imagining with a PET/MRI alone is acceptable on study. If a PET/CT is performed, a separate pancreas protocol CT is required for inclusion.
  • Must have received neoadjuvant chemotherapy at the discretion of medical oncology
  • Medical oncology consultation to confirm that patient is an appropriate candidate for concurrent chemotherapy and surgical oncology consultation for confirmation of resection status.

Note: Patients who have received previous chemotherapy for pancreatic cancer are allowed to participate in this study, unless they experienced a previous allergic reaction to the drugs used in this study.

  • Planned to receive CRT, consisting of PBT or IMRT (45 Gy/15 fractions) with concurrent chemotherapy with 5FU or Capecitabine.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or Karnofsky Performance Status 70-100 (Appendix III).
  • Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB 15-000136
  • Patients do not need to agree to Biobank blood draw.
  • Patients at Mayo Clinic Arizona are not required to consent to the Registry.
  • Willing to sign consent for blood collection onto the Pancreas SPORE, IRB 354-06.
  • Able to complete standard of care clinical questionnaire(s) by themselves or with assistance.

Exclusion Criteria:

  • Presence of non-regional nodal involvement or distant metastatic disease (M1)
  • Prior RT to the thorax, abdomen, or pelvis
  • History of prior malignancy < 2 years of enrollment, except non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • Immunocompromised patients and patients known to be HIV positive and not currently receiving antiretroviral therapy.

Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.

  • Receiving any investigational agent concurrent with CRT which would be considered as a treatment for the primary neoplasm.

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic or psychiatric illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Contacts and Locations
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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): NCT03902600


Contacts
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Contact: Jessica Clinical Research Coordinator 507-293-2668 Schneider.Jessica1@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Terence Sio, MD         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Kenneth Merrell, MD         
Principal Investigator: Krishan Jethwa, MD         
Sponsors and Collaborators
Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Kenneth W. Merrell, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03902600    
Other Study ID Numbers: 17-011198
ROR1741 ( Other Identifier: Mayo Clinic )
NCI-2021-13235 ( Other Identifier: NCI )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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