Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
The goal of this clinical trial is to learn if Adaptive Radiation Therapy (ART) is safe and effective in treating patients with locally advanced pancreatic cancer.
The main questions the study aims to answer are:
* Can ART improve how well radiation therapy targets the most aggressive cancer cells, while protecting the healthy tissue around the tumor? * Can ART help reduce the side effects that participants may experience during treatment?
Participants will:
* Undergo CT scans to plan the exact location of the radiation treatment. During this process, 1-3 small markers may be placed in or near the tumor to help with the planning. * Have a tumor biopsy, which involves taking a small sample of tissue from the cancer. * Receive 5 radiation treatments every other day over a 2-week period. * Provide blood samples before, during, and after your radiation treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have histologically or cytologically-confirmed PDA.
Patients must have locally advanced unresectable PDA.
Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of chemotherapy must occur at least 2 weeks before start of ART.
Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
Disqualifiers
Radiologically or cytologically confirmed metastatic disease.
Patients who have had any prior radiation therapy for pancreatic cancer.
Patients who have had prior chemoradiation to an overlapping volume.
Patients with adenosquamous carcinoma of the pancreas.
Trial design
Design model
Single group
Treatments tested in this trial
Adaptive Radiation Therapy
RadiationAdaptive Radiation Therapy (ART) creates a personalized radiation plan for each treatment session. This means the plan can change from day to day to more precisely target the tumor while protecting the surrounding healthy tissue. By closely shaping the radiation to match the tumor's location, ART may reduce the amount of radiation reaching nearby normal tissues. This can allow for higher, more focused doses of radiation to the tumor itself, which may help improve treatment effectiveness while reducing side effects.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Single-ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The rate of acute and late grade ≥3 gastrointestinal toxicity occurring within 3 months of treatment possibly, probably or definitely related to radiation.
Time frame
From start of radiation to 3 months after the end of radiation treatmentSecondary outcomes
1
The proportion of patients experiencing local control defined as stable disease or any response at the radiation target site(s).
Time frame
From the start of radiation to 5 years after end of radiation treatment2
Overall Survival Rate - defined as the time from the start of radiation to death or last contact. Individuals who are alive at last follow-up will be considered censored at the time of last contact.
Time frame
From the start of radiation to death or last contact (up to 5 years after end of treatment).3
The rate of acute and late adverse events at time points prescribed in the study calendar using CTCAE version 5.0.
Time frame
From start of radiation to end of long-term follow up (up to 5 years)Sponsors and contacts
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Source ClinicalTrials.gov