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治験 NCT05775146（対象：大腸がん、結腸がん肝転移）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases 第II相・フェーズ2 24
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05775146 は 大腸がん、結腸がん肝転移 に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2024年6月18日 から開始しています。24 名の参加者 の募集が計画されています。この試験は AHS Cancer Control Alberta によって主導され、2028年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年6月27日 です。
概要
The purpose of this study is to prospectively evaluate the feasibility of SBRT for the management of synchronous oligo metastatic liver metastases from colorectal cancers.
詳細説明
This will be a phase II feasibility trial to evaluate ablative radiation for the management of colorectal cancer with potentially resectable/ablatabale synchronous oligo-metastases.
In this study, following completion of the neo-adjuvant component of treatment, patients will be re-staged (as is the current standard of care) and can then proceed for SBRT to the liver lesion. Patients who may have responded very well ...
もっと見る公式タイトル
Phase II Single Arm Feasibility Trial to Evaluate Stereotactic Ablative Radiation of Metastases for the Management of Colorectal Cancer With Synchronous Oligo-metastases in Liver
疾患名
大腸がん結腸がん肝転移その他の研究識別子
- IIT-0023
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的SBRT to the metastatic liver +/- lung lesions All rectal cancer patients included in the trial will receive short course radiation to the pelvis (with 25 Gy in 5 fractions) followed by chemotherapy with either 6 cycles of 3 weekly CAPOX chemotherapy or 9 cycles of 2 weekly FOLFOX. All colon cancer patients will receive 6 cycles of 3 weekly CAPOX or 9 cycles of 2 weekly FOLFOX. Patients will proceed for SBRT to the metastatic liver +/\_ lung lesions and resection...もっと見る | stereotactic body radiation treatment (SBRT) SBRT uses 3D imaging to target high doses of radiation to the affected area. There is very little damage to the surrounding healthy tissue. SBRT works by damaging the DNA of the targeted cells. Then, the affected cells can't reproduce, which causes tumors to shrink. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Progression free survival (PFS) | Defined as Time from diagnosis to disease progression at any site or death | From date of diagnosis upto 24 months in follow up |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Quality of Life (QOL)C309v3 | To study the Quality of Life as measured by QLQ (quality of life questionnaire)-C309v3) | Baseline QOL will be assessed upto 24 months follow up |
Quality of Life (QOL)EORTC | To study the Quality of Life as measured by QLQ (quality of life questionnaire)- EORTC CR29 Questionnaire | Baseline QOL will be assessed upto 24 months follow up |
Cancer Specific Survival (CSS) | Defined as the time from diagnosis to death due to the cancer | Upto 24 months |
Overall Suvival(OS) | Defined as the time from diagnosis to death due to any cause . | Expected to be within 3 months post treatment |
Toxicity Assessment | Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 | Toxicity assessment will be done upto 24 months in follow up |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) 0-2
- Able to provide written informed consent
- 1-5 Liver lesions with max size of ≤5cm for a single lesion and restricted to one lobe of liver; deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent
- Liver lesion identified within 3 months of diagnosis of primary and deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent
- Plan for resection of primary with curative intent
- Patients with liver metastases and potentially resectable/ablatable lung mets can be included.
- Colon cancer patients who have undergone upfront resection of primary colonic lesion can be included
- Able and willing to comply with the terms of the protocol including health-related quality of life (HRQoL) questionnaires
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.
- Females must not be breastfeeding
- Male patients should agree to not donate sperm during the study
- Extra-hepatic metastases (except potentially resectable lung mets)
- Not a suitable candidate for liver resection surgery
- Not a suitable candidate for SBRT
- Past history of cancer within 5 years (except basal cell carcinoma)
- Patients who have undergone previous surgery or ablation for liver lesions
- Planned simultaneous resection of primary and liver metastases
- Pregnancy
- Patients with Child-Pugh C and documented cirrhosis
AHS Cancer Control Alberta試験中央連絡先
連絡先: Aswin Abraham, 780-432-8516, [email protected]
1 1カ国の場所
Alberta
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Aswin Abraham, 連絡先, 7804328516, [email protected]
募集中