Safety of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma

Launched by CAPITAL HEALTH SYSTEM, INC · Aug 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Cyberknife, which uses a type of radiation therapy known as Stereotactic Body Radiation Therapy (SBRT), for patients with borderline resectable or locally advanced pancreatic cancer. The researchers hope that this treatment will help shrink the tumors so they can be surgically removed. They also want to see if patients who receive SBRT experience a better quality of life compared to those receiving a different type of radiation therapy called IMRT.

To participate in the trial, patients must be 18 years or older, have completed a specific chemotherapy treatment, and have a confirmed diagnosis of Stage I to Stage III pancreatic cancer. They should not have any signs of cancer spreading to other parts of the body and must be able to understand the consent process. The trial is currently recruiting participants, and it is important to know that certain individuals, like those with certain types of heart devices or pregnant women, may not be eligible. Participants will receive careful monitoring and support throughout the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to sign the informed consent and understand the consenting process
• • Completed neoadjuvant chemotherapy regimen
• • Patient is 18 years of age and older
• • Eastern Cooperative Oncology Group (ECOG) Status of 0-1.
• • Patient has a diagnosis of Stage I to Stage III pancreatic cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria and NCCN guidelines, based on radiographic imaging or exploratory laparoscopic surgery, low degree of arterial involvement (CA, CHA, SMA) and no aorta involvement.
• • Patients who are deemed eligible for IMRT or SBRT and approved to receive radiation therapy by multidisciplinary tumor board
• • Patient shows no evidence of disease progression to distant metastasis based on NCCN.
• • Negative pregnancy test
• Exclusion Criteria:
• • Pregnant or lactating female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of radiation therapy.
• • Resectable pancreatic cancer (See addendum, NCCN Guidelines 2021, PANC-2)
• • Unresectable pancreatic cancer (See addendum, NCCN Guidelines 2021, PANC-6)
• • Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade.
• • Patients with implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity.
• • Life expectancy of \< 1 year