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New treatment option for Pancreatic Cancer
Official title Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain
ClinicalTrials.gov ID: NCT07117032
What this study is testing
- What it's testing
- Participants who are experiencing abdominal pain due to having cancer in their pancreas may be eligible for this research study. For this type of pain, doctors often recommend radiation therapy to help with the pain.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the...
- Age \>18 years. Because no data are currently available on the use of celiac axis SBRT in participants ≤18 years of age, children are excluded from...
- Performance status: ECOG Performance status ≤ 3
- Severe retroperitoneal pain syndrome (radiates from the lower back to the upper abdomen, belt- like distribution), intensity of at least 5 on...
- Participants must have anatomical involvement of the celiac plexus on the diagnostic CT, PET/CT, or MRI. This includes:
You likely can't join if
- Prior radiotherapy to the upper abdomen.
- Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
- Pregnant or breastfeeding women are excluded from this study.
- Participants with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.
- Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as...
See the full eligibility criteria
- Participants must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the treating physician to receive celiac plexus SBRT.
- Age \>18 years. Because no data are currently available on the use of celiac axis SBRT in participants ≤18 years of age, children are excluded from this study.
- Performance status: ECOG Performance status ≤ 3
- Severe retroperitoneal pain syndrome (radiates from the lower back to the upper abdomen, belt- like distribution), intensity of at least 5 on 11-point Brief Pain Inventory (BPI, average pain) scale despite analgesic...
- Participants must have anatomical involvement of the celiac plexus on the diagnostic CT, PET/CT, or MRI. This includes:
- Any pancreatic cancer
- Any other cancer that on imaging demonstrates either gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels that typically implies tumor engulfment.
- Prior chemotherapy or biological treatment is allowed, but any active oncological treatment must be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
- Participants must have a diagnostic CT, PET/CT, or MRI of the abdomen and pelvis, with or without contrast, acquired \< 28 days prior to the study consent. This diagnostic scan, to be used for pre-plan formation, must...
- Prior radiotherapy to the upper abdomen.
- Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
- Pregnant or breastfeeding women are excluded from this study.
- Participants with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.
- Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.