A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metast… (NCT03902600) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer
United States103 participantsStarted 2018-05-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, borderline resectable, or unresectable disease as per National Comprehensive Cancer Network (NCCN) classification. When CT of the chest, abdomen, and pelvis are performed, this must be with contras per pancreas protocol. Imagining with positron emission tomography (PET)/magnetic resonance imaging (MRI) alone is acceptable on study. If 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 proton beam therapy (PBT) or intensity-modulated radiation therapy (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…