Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain (Celiac SRS)
2026年7月29日 更新者：University Health Network, Toronto
A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
This is a prospective, single-arm, pilot feasibility clinical trial designed to evaluate the feasibility and safety of a simulation-free adaptive radiotherapy workflow to enable single-session celiac plexus SBRT planning and delivery.
In this trial, the treatment itself is non-investigational (standard-of-care celiac plexus SBRT) but the treatment workflow (simulation-free, using adaptive radiotherapy to compress treatment planning and delivery into a single session) is novel.
Investigators hypothesize the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.
調査の概要
詳細な説明
A standard treatment for pain caused by cancer affecting the celiac plexus (a group of nerves in the upper abdomen behind the stomach and pancreas) is a type of radiation therapy called stereotactic body radiotherapy (SBRT).
In the usual process for this type of radiation treatment, the patient would first have a special radiation planning scan called a computer tomography simulation (CTsim) to create a personalized treatment plan.
The planning process usually takes 5 to 10 days, which means treatment may begin up to 2 weeks after the initial CTsim scan.
Recent technology has allowed for treatment to be planned without a separate CTsim scan, called a CTsim-free workflow.
In this study, investigators will use pre-existing scans (such as diagnostic imaging) to create the patient's treatment plan.
On the day of treatment, the care team will use a technique called Adaptive Radiotherapy (ART) to adjust the plan based on the patient body's position and anatomy that day, allowing planning and treatment to happen in a single visit.
研究の種類
介入
入学 (推定)
5
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Michael Yan
- 電話番号：(416) 946-2320
- メール：michael.yan@uhn.ca
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M5G 2M9
- 募集
- Princess Margaret Cancer Centre
-
主任研究者：
- Michael Yan
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Subjects 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 subjects ≤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.
- Subjects 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 should be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Subjects must have a diagnostic CT of the abdomen and pelvis, with or without contrast, acquired < 28 days prior to the study consent.
Exclusion Criteria:
- In ability to tolerate lying supine and still for at least 45 minutes.
- Performance status: ECOG Performance status of 4.
- Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
- Pregnant or breastfeeding women are excluded from this study.
- Subjects 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, documentation of this exception is sufficient in lieu of a pregnancy test.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sim-free ART workflow
|
Simulation-free radiation treatment planning, in which pre-existing diagnostic images are used to generate a radiation treatment pre-plan (as opposed to acquiring planning-specific image sets).
This will be paired with the use of online adaptive radiotherapy (ART) to refine the pre-plan to create a final plan that matches the on-table internal target and gastrointestinal anatomy observed with on-board imaging on the day of treatment.
This enables single-session celiac plexus SBRT planning and delivery.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Successful treatment plan workflow of 80% of patients
時間枠：1 year
|
The feasibility and safety of the simulation-free adaptive radiotherapy workflow for celiac plexus SBRT for clinical use. Feasibility defined as the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients. All of the following criteria must be met to be deemed feasible:
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Component time
時間枠：1 year
|
Average time required for each component of the simulation-free ART workflow, including but not limited to plan generation using diagnostic imaging, pre-treatment activities (e.g., on-table patient setup/imaging, dose prediction, segmentation of daily contours, plan optimization and evaluation), and treatment delivery.
|
1 year
|
|
Dosimetric comparison of radiation plans
時間枠：1 year
|
Dosimetric comparison of radiation plans created on traditional offline CBCT images with those created using the simulation-free ART workflow (i.e., comparison of target coverage, sparing of organs-at-risk).
|
1 year
|
|
Frequency of online re-adaptation
時間枠：1 Year
|
Frequency of online re-adaptation within the sim-free workflow.
Readaptation defined as the need to regenerate a treatment plan after an initial plan had been generated that does not satisfy treatment parameters.
|
1 Year
|
|
Patient satisfaction
時間枠：1 year
|
Overall patient satisfaction with celiac plexus SBRT using a simulation-free, adaptive radiotherapy workflow.
This will be assessed using the Radiotherapy Experience Questionnaire (RTEQ) which is a validated RT experience questionnaire that reports patient experiences with the overall treatment process by answering statements on a scale of strongly agree to strongly disagree.
Given that this is a novel workflow/process, the results of the questionnaire will shed light on their overall experience.
|
1 year
|
|
TCAE Grade 3+ Toxicity
時間枠：6 weeks
|
Any CTCAE Grade 3+ Toxicity at 6 weeks related to the SBRT treatment.
|
6 weeks
|
|
Cost of workflow
時間枠：1 year
|
The overall cost of simulation free workflow compared to select retrospective cases treated on conventional workflow.
Timepoints include simulation, planning, treatment, and follow up.
Components include planning, therapist, clinician.
|
1 year
|
|
Mean difference between diagnostic and ETHOS plans (COM)
時間枠：1 year
|
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk.
These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel.
Rigid registration to spinal column as baseline (or aorta).
Metrics will include center of mass (COM).
|
1 year
|
|
Mean difference between diagnostic and ETHOS plans (DTA)
時間枠：1 year
|
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk.
These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel.
Rigid registration to spinal column as baseline (or aorta).
Metrics will include distance to agreement (DTA).
|
1 year
|
|
Mean difference between diagnostic and ETHOS plans (ASSD)
時間枠：1 year
|
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk.
These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel.
Rigid registration to spinal column as baseline (or aorta).
Metrics will include average symmetric surface distance (ASSD).
|
1 year
|
|
Mean difference between diagnostic and ETHOS plans (DSC)
時間枠：1 Year
|
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk.
These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel.
Rigid registration to spinal column as baseline (or aorta).
Metrics will include dice for volume overlap (DSC).
|
1 Year
|
|
Mean difference between diagnostic and ETHOS plans (DVF)
時間枠：1 Year
|
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk.
These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel.
Rigid registration to spinal column as baseline (or aorta).
Metrics will include deformation vector field (DVF).
|
1 Year
|
|
Change in the Brief Pain Inventory pain scale
時間枠：6 Weeks
|
Change in Brief Pain Inventory pain scale, where on a scale 0 is "No Pain" and 10 is "Pain as bad as you can imagine", recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT.
|
6 Weeks
|
|
Change in Amount of Pain Medication
時間枠：6 weeks
|
Change in the amount of pain medications (Morphine equivalents) recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT.
Patients will record number of medication units taken (unit of medication is a tablet or capsule, a millilitre (mL) of liquid, a suppository, or a patch).
|
6 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月4日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年5月26日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月30日
QC基準を満たした最後の更新が送信されました
2026年7月29日
最終確認日
2026年7月1日
詳しくは
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