CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL)
Safety and Feasibility of CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL): an Open-label, Single-arm Phase 1-2 Feasibility Study
Pancreatic ductal adenocarcinoma is a highly lethal cancer, and approximately 40% of patients present with non-metastatic locally advanced pancreatic cancer (LAPC) that is not suitable for surgical resection. To improve outcomes in this patient group, local ablative treatments are being explored. Radionuclide therapy (RNT) is a promising option that delivers high-dose internal radiation directly into the tumor, potentially achieving better local tumor control while sparing surrounding tissues compared with external-beam radiation therapy. The OncoSil™ device is a type of RNT containing Phosphorus-32-radiolabeled microparticles. The ³²P microparticles have been designed to deliver a localized distribution of beta-radiation within the target tumor up to 100 Gy, which causes direct damage to cancer cell DNA and renders them incapable of further cell division and proliferation. Favorable results have been reported by implanting ³²P microparticles intra-tumorally, which is typically administered via endoscopic ultrasound guidance. A percutaneous approach may allow for more precise and reproducible delivery, but prospective data on its safety and feasibility are lacking.
This prospective, single-arm phase 1-2 feasibility study aims to evaluate the safety and feasibility of percutaneous CT- guided RNT using ³²P microparticles in patients with non-progressive LAPC following induction chemotherapy. Twenty adult patients with pathology-confirmed LAPC, showing non-progressive disease according to RECIST, will be included after multidisciplinary tumor board review. Patients will undergo percutaneous, CT-guided implantation of ³²P microparticles under general anesthesia, sedation, or local analgesia depending on study phase and clinical judgment, followed by continuation of standard systemic chemotherapy and routine follow-up.
The primary endpoint is the rate of adverse events (CTCAE grade ≥3) occurring during the procedure and within 90 days afterward. Secondary endpoints include technical success, all adverse events, best overall respons, overall and progression-free survival, and changes in tumor markers.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Danielle J.W. Vos
- 電話番号：+31204444571
- メール：d.vos@amsterdamumc.nl
研究場所
-
-
North Holland
-
Amsterdam、North Holland、オランダ、1081 HV
- 募集
- Amsterdam UMC - location VUmc
-
コンタクト：
- Danielle J.W. Vos
- 電話番号：+3120-4444571
- メール：interventieradiologie@amsterdamumc.nl
-
-
参加基準
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
説明
Inclusion Criteria:
- Age ≥18 years
- Locally advanced pancreatic cancer, defined by the DPCG consensus criteria as: arterial involvement >90 degrees or venous involvement >270 degrees.
- At least RECIST stable disease after a minimum two months of chemotherapy according to current clinical practice*
- Capable of providing written and oral informed consent
- Candidate for RNT, judged by a multidisciplinary tumor board
- WHO 0-2
Exclusion Criteria:
- Eligibility for resection
- Participation in other trials focussing on different ablative treatment modalities such as radiofrequency ablation or irreversible electroporation for LAPC
- Known hypersensitivity to silicon or phosphor
- Bleeding disorders which cannot be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- Pregnancy
- Metastatic pancreatic cancer
- Epilepsy episode(s) in the past six months
- Longest tumor diameter >70 mm or total target tumor volume >110 ml
- Presence of multiple collateral vessels surrounding or adjacent to the target tumor on radiologic imagining, prohibiting safe injection of the OncosilTM device
- Presence (or significant risk) of varices near the target tumor on radiologic imaging
- Recent clinically significant pancreatitis
- Previous administration of radiotherapy to the pancreas
研究計画
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：CT-guided percutaneous intratumoural implantation of ³²P microparticles for LAPC
CT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy.
|
CT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy.
|
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 |
時間枠 |
|---|---|
|
Safety defined as the rate of procedure- or device-related CTCAE grade ≥3 adverse events (AEs) within 90 days after implantion.
時間枠：From implantation to 90 days after implantation
|
From implantation to 90 days after implantation
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Technical succes defined a the rate of adequate punctures and subsequent complete intratumoral delivery of the planned dose.
時間枠：Periprocedural.
|
Periprocedural.
|
|
Overall safety defined as the rate of adverse events.
時間枠：From implantation until 90 days after implantation.
|
From implantation until 90 days after implantation.
|
|
Duration of implantation procedure defined as the total time of punction.
時間枠：Periprocedural.
|
Periprocedural.
|
|
Duration of overall procedure defined as the total time in the radiology suite.
時間枠：Periprocedural.
|
Periprocedural.
|
|
Overall survival
時間枠：Defined from diagnosis and from implantion untill death by any cause, assessed up to end of study or up to 1 year after implantation.
|
Defined from diagnosis and from implantion untill death by any cause, assessed up to end of study or up to 1 year after implantation.
|
|
Local, distant and overall progression free survival
時間枠：Defined from diagnosis and from implantation until local and/or distant progression, or death, assessed up to end of study or up to 1 year after implantation.
|
Defined from diagnosis and from implantation until local and/or distant progression, or death, assessed up to end of study or up to 1 year after implantation.
|
|
Changes in serum CA19.9 during the first three months after implantation.
時間枠：From implantation until three months after implantation.
|
From implantation until three months after implantation.
|
|
Visual confirmation of intra-tumoral delivery of ³²P microparticles or other off-target deposition.
時間枠：SPECT-imaging at +4 hours and +7 days after implantation.
|
SPECT-imaging at +4 hours and +7 days after implantation.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NL78596.000.22
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。