Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®
キーワード
概要
説明
CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.
Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.
日付
| 最終確認済み: | 06/30/2020 |
| 最初に提出された: | 07/22/2019 |
| 提出された推定登録数: | 07/22/2019 |
| 最初の投稿: | 07/24/2019 |
| 最終更新が送信されました: | 07/16/2020 |
| 最終更新日: | 07/20/2020 |
| 実際の研究開始日: | 04/29/2020 |
| 一次完了予定日: | 11/30/2021 |
| 研究完了予定日: | 07/31/2025 |
状態または病気
介入/治療
Device: CivaSheet Treatment
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: CivaSheet Treatment Implanted with CivaSheet during tumor removal | Device: CivaSheet Treatment Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence |
適格基準
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Subject Signed Inform Consent 2. Subject plans to remain in the long-term care of his/her enrolling center/investigators. 3. Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate. 4. Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk 5. Subject is able to undergo surgery Exclusion Criteria: 1. Is unable or unwilling to comply with protocol requirements. 2. Is enrolled in another study/registry not approved by CivaTech Oncology. 3. Pregnancy, breast feeding |
結果
主な結果の測定
1. Rate of acute toxicity [90 days post implant]
二次的な結果の測定
1. Local control rate [5 years]
2. Reoperation rate [5 years]
3. Complication rate [6 months]
4. Dose to target and OAR [90 days]
